[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positive-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positive-breast-cancer":690},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,106,0,25,[9,47,70,149,170,205,231,248,271,293,318,337,355,374,416,444,467,490,515,536,573,596,616,634,656],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100600814",false,"NCT07102381","A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","EmpowHER 208","Inclusion Criteria:\n\n1. Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma.\n2. Has histologically confirmed HER2-positive breast cancer\n3. Has a known hormone receptor (HR) status of the primary tumor\n4. Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive.\n5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.\n6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate organ function\n8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization.\n9. Adequate contraceptive precautions\n10. Participants with known HIV are eligible unless:\n\n    1. CD4+ T Cell count is less than or equal to 350 microliters (uL)\n    2. Detectable viral load, or\n    3. Receiving protease inhibitors or cobicistat\n\nExclusion Criteria:\n\n1. Has Stage IV (metastatic) breast cancer.\n2. Has bilateral breast cancer.\n3. Has a history of any severe and\u002For uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study.\n4. Has uncontrolled hypertension\n5. Has significant symptoms from peripheral neuropathy\n6. Has an active uncontrolled infection\n7. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions.\n8. Known active hepatitis B or C infection.\n9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible.\n10. Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer\n11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol\n12. Receipt of a live vaccine within 4 weeks prior to enrollment\n13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy","ALL","18 Years",{"count":20,"type":21},125,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer",[27,28],"HER2-positive Breast Cancer","Breast Cancer",[30,31,32,33],"HER2-positive early breast cancer","invasive breast carcinoma","zanidatamab","breast neoplasm","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2025-09-24",{"date":42,"type":21},"2030-08-01",{"name":44,"class":45},"Jazz Pharmaceuticals","INDUSTRY",30,{"id":48,"slug":4,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100644772","NCT07673029","A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer","A Phase III, Multicenter, Open-label, Randomized Controlled Study Comparing GQ1005 and Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane","Inclusion Criteria:\n\n* Male or female adults ≥ 18 years at the time of voluntary signing of informed consent.\n* Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane\n* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.\n* Presence of at least one measurable lesion according to RECIST v1.1\n* Expected survival time ≥ 12 weeks.\n* Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study NOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.\n\nExclusion Criteria:\n\n* Prior anti-HER2 ADC therapy.\n* Previous history of interstitial lung disease\u002Fnoninfectious pneumonitis\u002Fradiation pneumonitis requiring steroid therapy.\n* Known serious hypersensitivity to the active ingredients of the study drug, inactive ingredients in the formulation, or other antibody drugs.\n* Multiple primary malignancies within 3 years, except for adequately resected non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast cancer\n* Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension, or other systemic disease that makes compliance with study procedures difficult\n* Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.","75 Years",{"count":55,"type":21},228,[57],"PHASE3","This study is designed to compare efficacy and safety of GQ1005 versus T-DM1 in HER2-positive, unresectable and\u002For metastatic breast cancer patients previously treated with trastuzumab and taxane.",[27],"2026-06-24",{"date":62,"type":38},"2026-06-29",{"date":64,"type":38},"2025-01-10",{"date":66,"type":21},"2028-01-09",{"name":68,"class":45},"GeneQuantum Healthcare (Suzhou) Co., Ltd.",70,{"id":71,"slug":4,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":111,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":78,"type":21},300,[80,24],"PHASE1","The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[83,84,85,86,87,88,89,90,91,28,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,27,109,110],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Colorectal Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt",{"date":141,"type":38},"2026-06-26",{"date":143,"type":38},"2020-10-29",{"date":145,"type":21},"2027-12-31",{"name":147,"class":45},"PMV Pharmaceuticals, Inc",77,{"id":150,"slug":4,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":166,"locationsCount":169},"100609700","NCT07217990","Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer","NoCUT-BC","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 years or older\n4. Early-stage breast cancer diagnosis (cT1-3 N0 or cT1-2 N1) and a Human Epidermal Receptor 2 (HER2)-positive or triple negative breast cancer (TNBC) tumor molecular subtype\n5. Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT)\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Inmate or prisoner\n3. Treatment with an investigational drug or other intervention throughout their breast cancer treatment\n4. Patients with skin involvement and\u002For distant metastases",{"count":156,"type":21},84,[80,24],"This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.",[28,27,103],"NOT_YET_RECRUITING","2026-06-20",{"date":60,"type":38},{"date":164,"type":21},"2026-09-15",{"date":145,"type":21},{"name":167,"class":168},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":171,"slug":4,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":193,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100431578","NCT04899908","Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases","A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone","Inclusion Criteria:\n\n* Participants must have a biopsy proven solid malignancy and at least one intracranial measurable lesion spanning ≥5mm in maximal unidimensional size and radiographically consistent with or pathologically proven to be a brain metastasis AND meet one of the following additional criteria regarding the primary site or nature of the intracranial disease:\n\n  * Melanoma with intracranial growth consistent with tumor progression despite immunotherapy\n  * Gastrointestinal primary\n  * HER2 positive breast cancer (subtype assessed using most representative tissue available in opinion of enrolling clinician and\u002For study PI)\n  * Cystic metastases\n  * Metastases ≥2cm in maximal unidimensional size\n  * Locally recurrent metastases after prior stereotactic radiation\n  * Locally recurrent metastases after prior whole brain radiation \\*Patients with metastases from melanoma, GI primaries, or HER2+ breast cancer, as well as those with cystic metastases or metastases ≥2cm in maximal unidimensional size, who have local recurrences after prior brain-directed radiation can only be treated in the strata permitting prior radiation (last two strata above)\n* Age ≥18 years at diagnosis of brain metastases\n* Estimated glomerular filtration rate of ≥ 60 mL\u002Fmin\u002F1.73m2\n* Karnofsky performance status of at least 70 (i.e. at minimum, \"cares for self\" but \"unable to carry on normal activity or do active work\")\n* Estimated survival based on extracranial disease of at least 3 months in the opinion of the enrolling clinician and\u002For study PI\n* Ability to understand and the willingness to sign a written informed consent document\n* The effects of AGuIX on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the therapeutic component of study participation\n\nExclusion Criteria:\n\n* Participants who cannot undergo a brain MRI\n* Participants who cannot receive gadolinium\n* Participants with widespread, definitive leptomeningeal disease\n* Patients requiring radiation to either \\>10 targets (if naïve to whole brain radiation) or \\>20 targets (if whole brain radiation has been given previously) per the discretion of the treating clinician and\u002For study PI\n* Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study\n* In cohorts who have received prior brain-directed radiation, patients are not eligible for this study if they have active (at the time of protocol screening) brain metastases that require radiation that are in or within 1.0cm of the brainstem, eyes, optic nerves, or optic chiasm if the juxtaposed organ at risk (i.e. brainstem, eyes, optic nerves, or optic chiasm) has previously received either \\>6.0 Gy in a single fraction or, if prior radiation was fractionated, a cumulative dose in 2.0 Gy equivalents, using an alpha\u002Fbeta ratio of 2, of \\>40.0 Gy. In addition, all patients who have had prior brain-directed radiation, regardless of technique\u002Fdose\u002Ffractionation, are not eligible for the study until written approval is provided by the study\u002Fsite PI",{"count":177,"type":21},134,[24],"The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone.",[181,182,183,87,28,27,91,184,185,186,187,188,189,190,191,192],"Brain Cancer","Brain Metastases","Melanoma","Gastrointestinal Cancer","SRS","SRT","Whole Brain Radiation","Stereotactic Radiation","AGuIX","Nanoparticle","Cystic","Brain Tumor",[181,182,183,87,28,27,91,184,185,186,194,188,189,190,191,192],"Whole brain radiation","2026-06-16",{"date":197,"type":38},"2026-06-17",{"date":199,"type":38},"2021-09-15",{"date":201,"type":21},"2029-05",{"name":203,"class":168},"Brigham and Women's Hospital",2,{"id":206,"slug":4,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":211,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":216,"conditions":217,"keywords":220,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":169},"100584649","NCT06892093","Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients","Efficacy and Safety of Probiotics Versus Standard Care in Preventing Diarrhea Induced by Neratinib in Breast Cancer Patients: A Prospective Randomized Controlled Clinical Trial","Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\n1. Female patients aged ≥18 years, diagnosed with HER2-positive breast cancer.\n2. Scheduled to receive Neratinib therapy (monotherapy or in combination), based on clinical guidelines.\n3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, with an expected survival of at least 3 months.\n4. Left ventricular ejection fraction (LVEF) ≥ 50%.\n5. Resolution of any prior treatment-related toxicity to Grade ≤1 (per CTCAE v5.0), with AST and ALT ≤ 2.5 × the upper limit of normal (ULN), and total bilirubin ≤ 1.5 × ULN.\n6. Adequate bone marrow function, defined as:\n\n   White blood cell count ≥ 3.0 × 10⁹\u002FL Neutrophil count ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL Serum creatinine ≤ 1.5 × ULN\n7. No persistent gastrointestinal symptoms, such as hematochezia, chronic constipation, or abdominal pain.\n8. No evidence of structural gastrointestinal abnormalities confirmed by gastroscopy or other relevant examinations.\n\nExclusion Criteria\n\nParticipants will be excluded if they meet any of the following criteria:\n\n1. Conditions that significantly impair swallowing, digestion, or gastrointestinal drug absorption.\n2. History of chronic gastrointestinal diseases, including but not limited to inflammatory bowel disease (IBD), gastrointestinal tumors, or malabsorption syndromes.\n3. Severe cardiovascular diseases that may interfere with study treatment, including but not limited to:\n\n   Life-threatening arrhythmias Advanced atrioventricular block Unstable angina Clinically significant pericardial disease Myocardial fibrosis Uncontrolled hypertension\n4. Known hypersensitivity to any component of Neratinib, probiotics, placebo, or loperamide.\n5. Prior participation in any clinical trial involving investigational drugs within 4 weeks prior to enrollment, or chronic use of medications that may induce constipation within 6 months.\n6. Pregnant or lactating women, or those unwilling to use effective contraception during the study period.\n7. Any medical, psychiatric, or social condition that, in the investigator's judgment, could compromise the safety of the participant, interfere with study participation, or confound the study results.","FEMALE",{"count":213,"type":21},308,[215],"NA","This study aims to evaluate the efficacy and safety of probiotics for the prevention of diarrhea in patients with breast cancer receiving the tyrosine kinase inhibitor (TKI) Neratinib.\n\nStudy Design: This is a prospective, randomized controlled clinical trial. Participants will be randomly assigned to either a probiotics intervention group or a placebo-controlled group. Both groups will receive prophylactic loperamide according to the FDA-recommended dosing schedule for neratinib-associated diarrhea.\n\nPrimary Objective: To evaluate the efficacy of probiotics in reducing the incidence and severity of diarrhea in patients receiving Neratinib.\n\nSecondary Objectives: This study will also investigate the effects of probiotics on gut microbiota composition and their potential impact on drug efficacy.\n\nStudy Duration: Enrollment is planned from August 2025 to June 2027 at Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University. Both the intervention and control groups will receive treatment for a total of six weeks (two cycles of three weeks each). No post-treatment observation period is included.\n\nEligibility Criteria: Participants must be diagnosed with HER2-positive breast cancer and scheduled to receive Neratinib. Exclusion criteria include patients with severe gastrointestinal disorders or recent probiotic consumption.",[27,218,219],"Diarrhea Caused by Drug","Neratinib",[219,221,222,28],"Probiotics","Diarrhea","2026-06-15",{"date":197,"type":38},{"date":226,"type":38},"2025-08-07",{"date":228,"type":21},"2027-12",{"name":230,"class":168},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":232,"slug":4,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":211,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":169},"100388039","NCT04332588","Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET\u002FMRI","Inclusion Criteria:\n\n1. Patients must be ≥ 18 years old and ≤ 75 years old\n2. HER2+ breast cancer determined on primary tumor by a local pathology laboratory and defined as IHC score 3+ and\u002For positive by ISH (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility\n3. Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment\n4. Estimated life expectancy of greater than one year\n5. Patients must have one lesion with RECIST measurable disease (great than 1 cm in diameter)\n\nExclusion Criteria:\n\n1. Inability to provide informed consent F\n2. Weight over 350 lbs., due to the scanner bore size\n3. Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum β-hCG pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 48 hours of each PET imaging study.\n4. Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)\n5. Unable to lie still on the imaging table for one (1) hour\n6. contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)",{"count":7,"type":21},[80],"The purpose of the study is to see if using an investigational drug called \\[18F\\]FMISO with PET\u002FMRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future.",[27],"2026-06-12",{"date":195,"type":38},{"date":243,"type":38},"2022-03-25",{"date":245,"type":21},"2027-08",{"name":247,"class":168},"University of Alabama at Birmingham",{"id":249,"slug":4,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":211,"minAge":18,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":259,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":169},"100642519","NCT07647263","Trastuzumab Rezetecan Neoadjuvant Therapy in THP-Insensitive HER2-Positive Early Breast Cancer","An Interventional, Multicenter Study of Trastuzumab Rezetecan as Neoadjuvant Therapy in Patients With THP-Insensitive HER2-Positive Early Breast Cancer","Inclusion Criteria:\n\n* 1.Age ≥18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and the patient must agree to use effective contraception during treatment.\n* 2.Pathologically confirmed invasive breast cancer, stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system, with HER2-positive disease defined as: immunohistochemistry (IHC) 3+; or IHC 2+ with confirmed HER2 gene amplification by fluorescence in situ hybridization (FISH).\n* 3.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.\n* 4.No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.\n* 5.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* 6.Ability to understand and provide written informed consent.\n* 7.Adequate organ function as evidenced by the following laboratory values:\n* Hemoglobin ≥90 g\u002FL\n* White blood cell count ≥3.5×10⁹\u002FL\n* Platelet count ≥100×10⁹\u002FL\n* Neutrophil count ≥1.5×10⁹\u002FL\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3× upper limit of normal (ULN)\n* Total bilirubin ≤1.5×ULN\n* Serum creatinine ≤1.5×ULN\n* 8.No evidence of myocardial ischemia on electrocardiogram (ECG); New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥55% on echocardiogram; cardiac biomarkers (cardiac troponin I \\[cTnI\\] and B-type natriuretic peptide \\[BNP\\]) within normal limits.\n* 9.All required baseline laboratory and radiologic examinations completed prior to neoadjuvant therapy.\n* 10.No dysphagia.\n* 11.Availability of complete clinical data.\n\nExclusion Criteria:\n\n* 1.Male breast cancer or inflammatory breast cancer.\n* 2.Metastatic breast cancer (Stage IV).\n* 3.Presence of other concurrent malignancies or history of malignancy other than breast cancer within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* 4.Receipt of any other concurrent anti-cancer therapy or participation in another clinical trial.\n* 5.Presence of severe non-malignant disease that would compromise patient compliance or place the patient at unacceptable risk.\n* 6.Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipated need for major surgery during the study period.\n* 7.Receipt of radiotherapy, chemotherapy, molecular targeted therapy, endocrine therapy, or major breast surgery for breast cancer within 4 weeks prior to study treatment; current or prior use of HER2-targeted monoclonal antibodies, HER2-targeted antibody-drug conjugates (ADCs), or tyrosine kinase inhibitors (TKIs).\n* 8.History of hypersensitivity or contraindication to any component of the study drugs.\n* 9.Poorly controlled cardiac symptoms or diseases, including: New York Heart Association (NYHA) Class II or higher heart failure; unstable angina; myocardial infarction within 1 year; clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n\nDementia, intellectual disability, or any psychiatric disorder that impairs the ability to understand the informed consent form.",{"count":255,"type":21},124,[24],"This study is a response-adapted, multicenter, interventional trial enrolling patients with HER2-positive early or locally advanced breast cancer. All enrolled patients will first receive 2 cycles of standard neoadjuvant THP regimen, consisting of a taxane, trastuzumab, and pertuzumab. After the initial 2-cycle treatment, tumor response will be evaluated by radiologic imaging and patient-derived organoid (PDO) drug sensitivity testing.\n\nPatients with an inadequate response to THP are defined as those with \\\u003C50% tumor size reduction on imaging, or failure to reach the PDO sensitivity threshold (\\\u003C80% tumor cell killing for HER2+\u002FHR- tumors; \\\u003C60% for HER2+\u002FHR+ tumors). These non-responders will switch to receive 4 cycles of trastuzumab rezetecan (SHR-A1811), a novel HER2-targeted antibody-drug conjugate (ADC). Patients with a favorable response (≥50% tumor reduction or meeting the PDO threshold) will continue with an additional 4 cycles of THP.\n\nThe primary objective is to evaluate the pathologic complete response (pCR) rate in THP non-responders after switching to trastuzumab rezetecan. Secondary objectives include objective response rate (ORR), event-free survival (EFS), overall survival (OS), 3-year invasive disease-free survival (iDFS), and safety profiles of both treatment strategies. Outcomes in patients who continue THP will be described for exploratory purposes.\n\nA total of 124 patients will be enrolled. This response-adapted, individualized strategy aims to provide an effective option for HER2-positive breast cancer patients with an inadequate early response to conventional THP neoadjuvant therapy.",[27],[28,260,261,262],"HER2-positive","Neoadjuvant therapy","Trastuzumab rezetecan","2026-06-09",{"date":223,"type":38},{"date":266,"type":38},"2026-03-24",{"date":268,"type":21},"2031-12",{"name":270,"class":168},"The First Affiliated Hospital of Soochow University",{"id":272,"slug":4,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":292},"100624769","NCT07413939","RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive","A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II\u002FIII Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases","BREnnA","Inclusion Criteria:\n\n* Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central laboratory.\n* Measurable disease as per by RECIST v1.1 in stage 1. Non-measurable disease allowed in stage 2.\n* Previously treated (stable or progressive) or previously untreated CNS metastases, or leptomeningeal metastases.\n* At least one prior line of anti-HER2-based therapy for LAI or metastatic disease.\n* Prior anti-HER2 antibody-drug conjugate (ADC), such as trastuzumab-deruxtecan (T-DXd) or trastuzumab emtansine (T-DM1), in any treatment setting. Participants without prior ADC therapy may only be enrolled if approved standard-of-care (SOC) anti-HER2 ADC is not locally accessible at screening, or if there is a prospectively documented clinical contraindication.\n* Prior tyrosine kinase inhibitor (TKI) in the (neo)adjuvant setting provided completion is \\> 12 months ahead of LAI occurrence. Prior treatment with TKIs for LAI\u002FMBC is not permitted.\n* Has protocol-defined adequate organ and bone marrow function.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Baseline left ventricular ejection fraction (LVEF) ≥ 50%.\n\nExclusion Criteria:\n\n* Concurrent anti-cancer treatment, or treatment with investigational therapy within 28 days prior to initiation of study treatment.\n* Known active\u002Funtreated hepatitis B or C or chronic liver disease.\n* Clinically significant cardiovascular disease or risk, including heart failure (New York Heart Association (NYHA) ≥ II), ischemic heart disease or recent coronary events\u002Finterventions, clinically significant arrhythmias or electrocardiogram (ECG) abnormalities, QT prolongation or risk of ventricular dysrhythmias, poorly controlled hypertension, peripheral arterial disease, dilated cardiomyopathy, or unstable angina.\n* Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome.\n* Concomitant use of any drug or herbal medicine known to strongly inhibit or induce CYP3A4 or CYP2C8 activity, oral coumarin-derivative anticoagulants.",{"count":279,"type":21},650,[24,57],"The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in combination with trastuzumab and capecitabine.",[27],"2026-06-08",{"date":285,"type":38},"2026-06-10",{"date":287,"type":38},"2026-05-21",{"date":289,"type":21},"2032-09-29",{"name":291,"class":45},"Hoffmann-La Roche",55,{"id":294,"slug":4,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":211,"minAge":18,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":169},"100643678","NCT07635342","Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer","Efficacy and Safety of Pyrotinib and Trastuzumab Combined With Pegylated Liposomal Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel for Injection Albumin Bound as Neoadjuvant Therapy for Early HER2-Positive Breast Cancer","Inclusion Criteria:\n\n* Female patients aged 18 to 65 years.\n* Patients with previously untreated invasive breast cancer confirmed by pathological examination.\n* HER2-positive breast cancer, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by in situ hybridization (ISH), regardless of hormone receptor status.\n* Clinical stage T2N0-3M0 or any T\u002FN1-N3M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.\n* At least one measurable lesion according to RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function, meeting all of the following criteria:\n* Hemoglobin ≥100 g\u002FL.\n* Absolute neutrophil count ≥1.5 × 10\\^9\u002FL.\n* Platelet count ≥100 × 10\\^9\u002FL.\n* Total bilirubin ≤1 × upper limit of normal (ULN).\n* Alanine aminotransferase and aspartate aminotransferase ≤1.5 × ULN.\n* Alkaline phosphatase ≤2.5 × ULN.\n* Blood urea nitrogen and serum creatinine ≤1.5 × ULN.\n* Left ventricular ejection fraction ≥55% by echocardiography.\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and agree to use appropriate contraception during the study and for 8 weeks after the last dose of study treatment.\n* Patients must voluntarily participate in the study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Prior receipt of any anti-tumor therapy, including chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy.\n* Concurrent receipt of any other anti-tumor therapy.\n* Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.\n* Stage IV breast cancer.\n* Breast cancer not confirmed by pathological examination.\n* History of other malignancies within 5 years, except cured carcinoma in situ of the cervix.\n* Severe dysfunction of major organs, including the heart, liver, or kidney.\n* Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that may affect drug administration or absorption.\n* Participation in another drug clinical trial within 4 weeks before enrollment.\n* Known history of allergy to any component of the study treatment.\n* History of immunodeficiency, including positive HIV test, hepatitis C virus infection, active hepatitis B virus infection, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n* History of any cardiac disease, including clinically significant arrhythmia requiring medication, myocardial infarction, heart failure, or any other cardiac disease judged by the investigator to make the patient unsuitable for this study.\n* Pregnant or breastfeeding women, women of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential unwilling to use effective contraception throughout the study.\n* Serious concomitant diseases that, in the investigator's judgment, may compromise patient safety or affect completion of the study, including but not limited to uncontrolled severe hypertension, severe diabetes mellitus, or active infection.\n* Clear history of neurological or psychiatric disorders, including epilepsy or dementia.\n* Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.","65 Years",{"count":301,"type":21},182,[24],"This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel for injection albumin bound as neoadjuvant therapy in patients with early HER2-positive breast cancer.\n\nEligible patients will receive 8 cycles of neoadjuvant treatment. Pyrotinib will be administered orally once daily, and trastuzumab will be administered intravenously every 3 weeks. During the first 4 cycles, patients will receive pegylated liposomal doxorubicin hydrochloride and cyclophosphamide. During the subsequent 4 cycles, patients will receive paclitaxel for injection albumin bound. The primary outcome is total pathological complete response rate. Secondary outcomes include breast pathological complete response rate, lymph node pathological complete response rate, objective response rate, event-free survival, distant disease-free survival, overall survival, and safety.",[27],[306,307,308,309],"Neoadjuvant Therapy","Pyrotinib","Trastuzumab","Pathological Complete Response","2026-06-03",{"date":263,"type":38},{"date":313,"type":38},"2024-04-30",{"date":315,"type":21},"2029-12-31",{"name":317,"class":168},"Hebei Medical University Fourth Hospital",{"id":319,"slug":4,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":211,"minAge":18,"maxAge":53,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":204},"100632783","NCT07518173","A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer","A Randomized Controlled Phase III Clinical Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Female patients aged ≥18 and ≤75 years at the time of signing the informed consent form;\n3. Expected survival time ≥12 weeks;\n4. Patients with histologically or cytologically confirmed, previously untreated, unresectable recurrent or metastatic HER2-positive breast cancer;\n5. Clear hormone receptor (HR) status;\n6. Agree to provide eligible tumor tissue specimens;\n7. Have at least one measurable target lesion as defined by RECIST v1.1;\n8. ECOG performance status score of 0 or 1;\n9. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n10. Organ function levels must meet the requirements;\n11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and must be non-lactating; all enrolled patients must use adequate and highly effective contraceptive measures throughout the entire treatment period and for 7 months after treatment completion.\n\nExclusion Criteria:\n\n1. Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose.\n2. Previously received ADC drug therapy with camptothecin derivatives as toxins.\n3. History of severe cardiovascular or cerebrovascular disease within six months before screening.\n4. Concomitant pulmonary disease resulting in severely impaired lung function.\n5. History of interstitial lung disease (ILD)\u002Finterstitial pneumonia requiring corticosteroid therapy, etc.\n6. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias.\n7. Diagnosed with another primary malignancy within 5 years before the first dose.\n8. Newly developed deep vein thrombosis within 14 days before screening.\n9. Hypertension poorly controlled by antihypertensive medications.\n10. Patients with active central nervous system metastases.\n11. History of severe allergic reactions to recombinant humanized antibodies or any excipient or component of BL-M07D1.\n12. History of autologous or allogeneic stem cell transplantation or organ transplantation.\n13. Previously received anthracycline therapy exceeding the prescribed dose limit.\n14. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection.\n15. Severe infection within 4 weeks prior to the first use of the study drug, etc.\n16. Patients with large serous cavity effusions, serous cavity effusions with obvious symptoms, or poorly controlled serous cavity effusions.\n17. Receiving systemic corticosteroid therapy \\>10 mg\u002Fday prednisone or equivalent prior to randomization, etc.\n18. Presence of severe neurological or psychiatric disorders.\n19. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent.\n20. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.\n21. Subjects planning to receive or having received live vaccines within 28 days before the first dose.\n22. Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance that may increase the risk of participating in the study, interfere with study results, or make the patient unsuitable for participation in the study in the investigator's opinion.",{"count":325,"type":21},596,[57],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 combined with Pertuzumab versus docetaxel plus Trastuzumab and Pertuzumab in patients with first-line HER2-positive recurrent or metastatic breast cancer.",[27],{"date":330,"type":38},"2026-06-04",{"date":332,"type":38},"2026-04-21",{"date":334,"type":21},"2029-12",{"name":336,"class":45},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":338,"slug":4,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":211,"minAge":18,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":345,"phases":4,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":169},"100411530","NCT04638725","Identification of Genetic Determinants for Treatment Resistance\u002FSensitivity and\u002For Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer","SIGHER","For inclusion in the study, patients must be affiliated to the national or local social security, and must meet all the following criteria:\n\nInclusion Criteria:\n\n* Age ≥ 18 years\n* Histological diagnosis of breast adenocarcinoma. Non-metastatic and operable.\n* Current or prior treatment with one therapy targeting HER2 in adjuvant or neoadjuvant phase for the current breast cancer\n* Given written informed consent\n\nExclusion Criteria:\n\n* Patients not able to comply to the protocol assessments for geographic, social or psychological reasons\n* Patients placed under judicial protection, guardianship, or supervision\n* History of cancer in the 5 years preceding anti-HER2 therapy initiation\n* Concomitant cancer (except for an other non metastatic cancer treated only with surgery)\n\nNote : Patients are eligible at any time of the follow-up if the adjuvant or neoadjuvant chemotherapy started after 01\u002F01\u002F2019. Patients treated with trastuzumab, pertuzumab, neratinib or T-DM1 in a clinical trial are eligible in the SIGHER study.",{"count":344,"type":21},9000,"OBSERVATIONAL","This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify constitutional genetic factors associated with histological response, resistance or sensibility to treatment in human epidermal growth factor receptor 2 (HER2)-positive breast cancer. 9000 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study. Patients will be treated and followed according to the standards of their treating center. They will be followed every six months for five years.",[27],{"date":330,"type":38},{"date":350,"type":38},"2021-12-15",{"date":352,"type":21},"2033-12-15",{"name":354,"class":168},"Centre Paul Strauss",{"id":356,"slug":4,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":211,"minAge":18,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":169},"100638727","NCT07616440","Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System Combined With Neoadjuvant Therapy for HER2-Positive Breast Cancer","Inclusion Criteria:\n\n1. Female patients aged 18-70 years.\n2. Histologically confirmed HER2 positive breast cancer, with indication for neoadjuvant chemotherapy, and scheduled to receive the T(P)CbHP neoadjuvant regimen.\n3. TNM stage T2N0-2M0.\n4. Adequate bone marrow reserve (ANC \\>1.5×10⁹\u002FL, platelets \\>100×10⁹\u002FL).\n5. Normal liver function (ALAT, ASAT, and bilirubin \\\u003C2.5× upper limit of normal).\n6. Adequate renal function (creatinine clearance \\>50 mL\u002Fmin).\n7. Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiography or MUGA.\n8. No psychological, family, social, or geographical conditions that would compromise compliance with the study protocol and follow-up schedule.\n9. No medical conditions that would place the subject at undue risk.\n10. Written informed consent signed by the subject.\n\nExclusion Criteria:\n\n1. Prior history of radiotherapy or chemotherapy.\n2. Pregnant or lactating patients.\n3. Presence of distant metastasis.\n4. Bilateral invasive breast cancer.\n5. Concurrent administration of other anticancer therapies or another investigational agent.\n6. inadequate physical tolerance, including significant cardiovascular, hepatic, or renal dysfunction, massive ascites, intestinal obstruction, severe infection, high fever, as well as water-electrolyte and acid-base imbalance.\n7. Patients with known hyper sensitivity to SonoVue®.","70 Years",{"count":362,"type":21},20,[215],"This study aimed to evaluate the feasibility and safety, and to observe early efficacy signals of the focused ultrasound mediated drug delivery system combined with SonoVue® in patients with HER2-positive breast cancer receiving neoadjuvant therapy by comparing its pathological complete response (pCR) rate with a matched historical cohort of HER2-positive breast cancer patients treated at our center.",[27],"2026-06-02",{"date":330,"type":38},{"date":369,"type":38},"2026-06-01",{"date":371,"type":21},"2027-01-31",{"name":373,"class":168},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":375,"slug":4,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":396,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":415},"100535595","NCT06253871","A Phase 1\u002F1b Study of IAM1363 in HER2 Cancers","A Phase 1\u002F1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Have relapsed\u002Frefractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required\n* Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy\n* Have radiographically measurable disease by RECIST v1.1 and\u002For RANO-BM\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-1\n* Have adequate baseline hematologic, liver and renal function\n* Have left ventricular ejection fraction (LVEF) ≥ 50%\n* Able to swallow oral medication\n\nKey Exclusion Criteria:\n\n* Clinically significant cardiac disease\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible\n* Current active liver disease including hepatitis A, hepatitis B , or hepatitis C\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption\n* Uncontrolled diabetes\n* History of solid organ transplantation\n* History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1\n* Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)\n* Participants requiring immediate local therapy for brain metastases",{"count":381,"type":21},383,[80],"This is a Phase 1\u002F1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.",[385,386,27,387,388,389,390,391,100,392,393,394,395],"HER2 Mutation-Related Tumors","HER2","HER2 + Breast Cancer","Brain Metastases From Solid Tumors","Brain Metastases From HER2 and Breast Cancer","CNS Metastases","HER2-Positive Solid Tumors","HER2-positive Bladder Cancer","HER2-positive Colorectal Cancer","HER2 + Gastric Cancer","HER2-positive Gastroesophageal Cancer",[397,398,399,400,401,402,403,404,405,406,386,407],"ERBB2 protein, human","Molecular Targeted Therapy","Genes, erbB-2","Receptor, ErbB-2 \u002F antagonists & inhibitors","Neoplasms \u002F drug therapy","HER2 positive","HER2 overexpressing","HER2 altered","Human epidermal growth factor receptor","ErbB Receptors","brain metastases",{"date":330,"type":38},{"date":410,"type":38},"2024-03-25",{"date":412,"type":21},"2028-12",{"name":414,"class":45},"Iambic Therapeutics, Inc",53,{"id":417,"slug":4,"hasResults":11,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":11,"sex":211,"minAge":18,"maxAge":360,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":169},"100484012","NCT05582499","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)","FASCINATE-N","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0;\n* Age between18-70 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* ER, PR and HER2 status were measured by immunohistochemistry (IHC);\n* LVEF≥55%；\n* Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\\&E slices;\n* Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;\n* At least one measurable lesion according to RECIST version 1.1\n* Normal organ and marrow function: Hemoglobin (HB) ≥90 g\u002FL (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 75,000\u002FμL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \\\u003C 1 x ULN, endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula);\n* Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;\n* Ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;\n* Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);\n* Patients with severe systemic infections or other serious diseases;\n* Patients with known allergy or intolerance to the study drug or its excipients;\n* Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;\n* Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;\n* Participated in other trial studies within 30 days before the administration of the first dose of the study drug;\n* Patients who were judged by the investigator to be unsuitable for this study.",{"count":424,"type":21},716,[24],"The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.",[428,28,429,430,27,109,431,432,433,434],"Breast Neoplasm","Breast Tumors","Triple-Negative Breast Cancer (TNBC)","Hormone Receptor Positive Tumor","Hormone Receptor Negative Tumor","Early-stage Breast Cancer","Locally Advanced Breast Cancer","2026-05-22",{"date":437,"type":38},"2026-05-28",{"date":439,"type":38},"2022-11-01",{"date":441,"type":21},"2029-09",{"name":443,"class":168},"Fudan University",{"id":445,"slug":4,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":22,"phases":451,"briefSummary":452,"conditions":453,"keywords":455,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":466},"100628287","NCT07459673","HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission","Inclusion Criteria:\n\n* Male or female participants who are ≥18 years old with histologically confirmed diagnosis of unresectable locally advanced or MBC.\n* Stage IV at the diagnosis (i.e., de novo metastatic) as per AJCC 8.\n* HER2 IHC results of 3+.\n* Life expectancy of ≥12 weeks.\n* Must be deemed medically fit for surgery and be surgical candidates upfront, or potentially operable if there is response to induction therapy.\n* Must have measurable disease per PERCIST 1.0.\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 14 days prior to the start of study intervention.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), as described in Appendix 3 during the intervention period. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n  * A WOCBP must have a negative urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of beta-human chorionic gonadotropin \\[β-hCG\\]) within 72 hours before the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n  * Additional requirements for pregnancy testing during and after study intervention are located in Appendix 2.The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n  * Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of therapy.\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n* Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n* Criteria for known Hepatitis B and C positive subjects: Hepatitis B and C screening tests are required as per MSK policy but do not need to be repeated prior to study unless there is a known history of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.\n* Participants who have active hepatitis B infection (defined as HBsAg positive and\u002For detectable HBV DNA) are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Participants should remain on anti-viral therapy throughout study intervention and follow MSK guidelines for HBV anti-viral therapy post completion of study intervention.\n* Participants with a history of HCV infection (defined as anti-HCV Ab positive and detectable HCV RNA) are eligible if HCV viral load is undetectable at screening.\n* Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\nTable 1 Adequate Organ Function Laboratory Values Hematological Absolute neutrophil count (ANC): ≥1500\u002FµL Platelets: ≥100 000\u002FµL Hemoglobin: ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL\n\nRenal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × ULN\n\nHepatic Total bilirubin: ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN AST (SGOT) and ALT (SGPT)\n\nCoagulation\n\nInternational normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT):\n\n≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. a Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. b Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.\n\nExclusion Criteria:\n\n* Patients diagnosed with HER2+ breast cancer as per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines with HER2 IHC results of 1-2+ and positive FISH or ISH\n* Prior exposure to anti-HER2 therapy of any kind or any systemic anti-cancer treatment of any kind for breast cancer.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 2 weeks prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses \\>10 mg daily of oral prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Inhaled, intranasal, intra-articular, or topical steroid use are allowed.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, which have undergone potentially curative therapy are not excluded.\n* Has known CNS metastases and\u002For leptomeningeal carcinomatosis.\n* Has a history or evidence of active pneumonitis or interstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has grade \\>=3 neuropathy of any etiology.\n* Has an active infection requiring antibiotics.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection.\n* Has an inability to swallow capsules or tablets.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has significant cardiovascular impairment within 12 months of the first dose of study drug: such as NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.\n* Has a left ventricular ejection fraction (LVEF) below the institutional normal range of 50%, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).\n* Known intolerance to any of the study drugs (or any of the excipients).\n* Has had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.",{"count":450,"type":21},60,[24],"Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential treatments (given one after another)-combined with local therapies (which treat cancer in a specific part of the body) and treatments that prevent cancer from spreading to the central nervous system (CNS; including the brain and spinal cord) can result in long-lasting remission and possibly cure some participants with HER2+ metastatic breast cancer.",[28,27,454],"Breast Cancer Stage IV",[456,27,454,457,458],"breast cancer","Memorial Sloan Kettering Cancer Center","25-258","2026-05-20",{"date":435,"type":38},{"date":462,"type":38},"2026-03-04",{"date":464,"type":21},"2030-03-04",{"name":457,"class":168},7,{"id":468,"slug":4,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":22,"phases":475,"briefSummary":476,"conditions":477,"keywords":479,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":204},"100448132","NCT05115474","Study of Screening Brain MRIs in Stage IV Breast Cancer","Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer","Inclusion Criteria:\n\n* Histologic diagnosis of breast cancer with documentation of ER\u002FPR\u002FHER2 status\n* Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+\u002FHER2- patients\n* Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients\n* Age ≥ 18\n* Life expectancy ≥ 6 months\n* Eastern Cooperative Oncology Group performance status 0 to 2\n* Patients must be able to understand and the willingness to sign an informed consent for study procedures\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Prior diagnosis or treatment of brain metastases or leptomeningeal disease\n* Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years\n* Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment\n* Indications warranting brain MRI for other neurologic conditions at time of study entry\n* Contraindication towards MRI imaging with contrast\n* Chronic kidney disease stage IV or V or end stage renal disease",{"count":474,"type":21},170,[24],"The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.",[103,27,478],"Hormone Receptor-positive Breast Cancer",[480],"Stage IV Breast Cancer","2026-05-14",{"date":483,"type":38},"2026-05-18",{"date":485,"type":38},"2021-12-21",{"date":487,"type":21},"2026-10",{"name":489,"class":168},"H. Lee Moffitt Cancer Center and Research Institute",{"id":491,"slug":4,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":22,"phases":498,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":466},"100597022","NCT07053085","A Study of Surgery and Radiotherapy in People With Breast Cancer","A Randomized Phase II Study of Consolidative Surgery and Radiotherapy With Curative Intent for De Novo Oligometastatic HER2+ Breast Cancer [Ablation and Resection for the Consolidation of Oligometastatic HER2+ Breast Cancer (ARCHER)]","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Pathologically-confirmed metastatic breast cancer.\n* Oligometastatic breast cancer (≤5 discrete metastatic lesions) without CNS involvement; as seen on standard imaging during initial workup and monitoring prior to registration.\n* HER2-positive breast cancer per CAP\u002FASCO guidelines as determined by staff pathologist (any estrogen or progesterone receptor status).\n* Based on size and location, all metastatic sites can be safely treated with either SBRT or resection.\n* Enrolled at least 3 months (and up to 12 months) after initiation of first-line systemic therapy AND without evidence of progression as determined by treating clinician (whether clinically or radiographically) during this window. (ie. in the judgement of the treating clinician, based on standard evaluations, all known disease must be controlled prior to enrollment).\n* ECOG performance status 0-2; KPS 60-100\n\nExclusion Criteria:\n\n* Any foci of disease progression during initial 3-12 months of first-line systemic therapy (as determined by treating clinician)\n* Escalation of systemic therapy line due to progressive disease (i.e. initiated second-line therapy prior to enrollment).\n* Comorbidities precluding receipt of radiotherapy, surgery or standard systemic therapy.\n* Intracranial or intrathecal\u002Fintramedullary spinal disease (ie. CNS involvement is excluded from the study; epidural\u002Fvertebral disease is permitted)\n* Prior cancer history requiring chemotherapy within the past 10 years (ie. prior cancers are permitted provided no chemotherapy was administered).\n\nInclusion of Underrepresented Populations\n\n* Individuals of all races and ethnic groups are eligible for this trial. There is no bias towards age or race in the clinical trial outlined. This trial is open to the accrual of men and women.",{"count":497,"type":21},178,[24],"The researchers are doing this study to see if the combination of surgery, locoregional radiation therapy, SBRT (stereotactic body radiation therapy), and the usual approach is more effective in treating oligometastatic HER2-positive breast cancer than the usual approach alone. The researchers will also study the side effects of the study treatment.",[501,27],"Metastatic Breast Cancer",[503,504,505,506,507],"Consolidative surgery","Radiotherapy","Ablation","Resection","25-145","2026-05-13",{"date":481,"type":38},{"date":511,"type":38},"2025-09-17",{"date":513,"type":21},"2029-09-17",{"name":457,"class":168},{"id":516,"slug":4,"hasResults":11,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":211,"minAge":18,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":4},"100641095","NCT07589699","Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP","A Single-Arm, Exploratory Study of 4 Additional Cycles of Trastuzumab Rezetecan (T-DXh) as Neoadjuvant Therapy in Patients With Early or Locally Advanced HER2-Positive Breast Cancer Who Have Non-pCR After TCbHP Neoadjuvant Therapy","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* For premenopausal and perimenopausal patients: negative pregnancy test and agreement to use reliable contraception during the treatment period.\n* Pathologically confirmed HER2-positive invasive breast cancer (IHC 3+ or IHC 2+ with FISH+).\n* Completed standard neoadjuvant TCbHP (taxane + carboplatin + trastuzumab + pertuzumab) with imaging assessment not achieving clinical complete remission (non-cCR).\n* Agree to undergo a core needle biopsy.\n* ECOG performance status 0 or 1.\n* Adequate organ function meeting the following criteria: hemoglobin ≥ 90 g\u002FL, white blood cell count ≥ 3.5 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL, absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, AST\u002FALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN.\n* No myocardial ischemia on ECG; New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥ 55% by echocardiography; cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) within normal limits.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Male breast cancer or inflammatory breast cancer.\n* Metastatic breast cancer (Stage IV).\n* Concurrent other malignancy or history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n* Concurrent other anti-tumor therapy or participation in another clinical trial.\n* Severe non-malignant disease that would affect compliance or place the patient at risk.\n* Major surgery within 4 weeks prior to start of study treatment or anticipated need for major surgery during the study.\n\nHistory of allergic reaction or contraindication to any component of the study drug.\n\n* Dementia, mental abnormality, or any psychiatric illness that interferes with understanding of the informed consent.\n* Any other condition assessed by the investigator as unsuitable for inclusion.",{"count":522,"type":21},59,[524],"PHASE4","This is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer who have residual invasive disease after standard 6-cycle TCbHP (taxane, carboplatin, trastuzumab, pertuzumab) neoadjuvant therapy. Patients will receive 4 cycles of T-DXh (4.8 mg\u002Fkg IV Q3W) followed by radical surgery. The primary endpoint is tpCR rate. Secondary endpoints include ORR, EFS, OS, 3-year iDFS, and safety. Simon's two-stage design (H0: pCR ≤10%, H1: pCR ≥25%, α=0.05, β=0.2) requires 43 evaluable patients; with 10% dropout, 48 patients will be enrolled.",[28,27,433,434],"2026-05-11",{"date":529,"type":38},"2026-05-15",{"date":531,"type":21},"2026-05-31",{"date":533,"type":21},"2031-12-31",{"name":535,"class":168},"The First Affiliated Hospital with Nanjing Medical University",{"id":537,"slug":4,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":22,"phases":545,"briefSummary":546,"conditions":547,"keywords":551,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":570,"locationsCount":572},"100136130","NCT01042379","I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)","I-SPY","Inclusion Criteria:\n\n* Histologically confirmed invasive cancer of the breast\n* Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)\n* No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed\n* Age ≥18 years\n* ECOG performance status 0-1\n* Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers\n* Non-pregnant and non-lactating\n* No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.\n* Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)\n* Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis\n* Any tumor ER\u002FPgR status, any HER-2\u002Fneu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F\n* Normal organ and marrow function: Leukocytes ≥ 3000\u002FμL, Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 100,000\u002FμL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)\u002FALT (SGPT) ≤ 1.5 x institutional ULN, creatinine \\\u003C 1.5 x institutional ULN\n* No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%\n* No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase\n* Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (\\\u003C5%), any HER2 status, or MammaPrint Low, ER positive, HER2\u002Fneu positive by any one of the three methods used (IHC, FISH, TargetPrint™)\n* Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)\n\nExclusion Criteria:\n\n* Use of any other investigational agents within 30 days of starting study treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":544,"type":21},5000,[24],"The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.",[548,28,429,549,550,27,109,431,432,433,434],"Breast Neoplasms","Angiosarcoma","TNBC - Triple-Negative Breast Cancer",[552,553,554,555,556,557,558,559,560,561,562,563],"Neoadjuvant","Breast","Cancer","Neoplasm","Adaptive","pCR","Pathologic Complete Response","Biomarkers signature","MRI Volume","Endocrine Therapy","Chemotherapy","Immunotherapy","2026-05-04",{"date":566,"type":38},"2026-05-06",{"date":568,"type":38},"2010-03-01",{"date":268,"type":21},{"name":571,"class":168},"QuantumLeap Healthcare Collaborative",42,{"id":574,"slug":4,"hasResults":11,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":581,"briefSummary":582,"conditions":583,"keywords":584,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":169},"100589053","NCT06949410","HER2 Vaccine for Locally Advanced Breast Cancer","Phase I Trial of a Chimeric (Trastuzumab-like and Pertuzumab-like) HER2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant for Locally Advanced HER2 Positive Breast Cancer","Inclusion Criteria:\n\n1. ≥ 18 years old at the time of informed consent\n2. Ability to provide written informed consent and HIPAA authorization CTO-IUSCC-0864\n3. Histologically confirmed HER2 positive breast cancer\n\n   1. Any Estrogen Receptor\u002FProgesterone Receptor status is allowed.\n   2. HER2 positive is defined as HER2 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \\> 2.0 or \\> 6 total HER2 gene copies per cell.\n4. High-risk disease defined as one of the following:\n\n   1. Any residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant taxane and trastuzumab-based chemotherapy\n   2. Inflammatory phenotype at the time of diagnosis per the treating physician\n   3. Clinical stage III disease at the time of diagnosis per the treating physician and\u002For clinical imaging\n   4. Locally recurrent disease and have undergone definitive local therapy\n5. Received at least six months of HER2 targeted therapy with trastuzmab +\u002F- pertuzumab TDM-1, or others in the neoadjuvant or adjuvant setting\n\n   a. Any combination of HER2 targeted therapy in the curative setting is allowed, including neratinib or others on a clinical trial\n6. Completed last dose of HER2 targeted therapy no more than 6 months prior to registration\n7. Completed last dose of cytotoxic chemotherapy or radiation at least 30 days prior to registration with resolution of any prior toxicity to ≤ 2 with the exception of alopecia\n8. ECOG performance status of 0 to 2\n9. Adequate organ function as indicated by:\n\n   1. Total bilirubin \\\u003C 1.5 mg\u002FdL (except in patients with documented Gilbert's disease, who must have a total bilirubin \\\u003C 3.0 mg\u002FdL)\n   2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.0 x ULN\n   3. Calculated creatinine clearance of \\> 60 mL\u002Fmin using the Cockcroft-Gault formula\n   4. Absolute neutrophil count (ANC) \\> 1.0 K\u002Fmm3\n   5. Platelets \\> 100 K\u002F mm3\n10. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) above the institutional lower limit of normal by echocardiogram or MUGA obtained within 90 days of registration\n11. Women of childbearing potential must have a negative serum pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:\n\n    1. Has undergone a hysterectomy or bilateral oophorectomy; or\n    2. Has been naturally amenorrheic for at least 12 consecutive months.\n12. Women of childbearing potential and men must agree to use one effective contraception throughout the study and for 6 months after the last study treatment.\n\nNote: Acceptable methods of birth control include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections).\n\nExclusion Criteria:\n\n1. Any distant disease recurrence.\n2. Patients with active malignancy other than breast cancer. Note: Patients with prior malignancies without recurrence after standard treatment will not be excluded.\n3. Patients receiving or planned to receive adjuvant CDK4\u002F6 inhibitor therapy\n4. Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.\n5. Patients who require or likely to require corticosteroids or other immunosuppressives\n6. Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome.\n\n   Note: At the discretion of the treating physician, patients who show disease control for at least 6 months and do not require immunosuppressives may be enrolled.\n7. Patients who have developed anaphylactic responses to other vaccines.\n8. Patients who have evidence of active infection that requires antibiotic therapy. Patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection.\n9. Known seropositive or active viral infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV). Seropositivity due to vaccination are eligible.\n10. Uncontrolled illness that would limit safety or compliance with study procedures including, but not limited to, active infection, congestive heart failure, unstable angina, or cardiac arrhythmia.\n11. Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases. At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.\n12. History of splenectomy\n13. Pregnant or breast feeding.",{"count":580,"type":21},36,[80],"The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.",[28,27],[585,586,587],"vaccine","immune system","immunotherapy",{"date":589,"type":38},"2026-04-22",{"date":591,"type":21},"2026-06",{"date":593,"type":21},"2030-03",{"name":595,"class":168},"Pravin T.P Kaumaya",{"id":597,"slug":4,"hasResults":11,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":22,"phases":604,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":415},"100431055","NCT04893109","ATEMPT 2.0: Adjuvant T-DM1 vs TH","A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0)","Inclusion Criteria:\n\n* Patients must have HER2-positive Stage I histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mic) breast cancer according to the AJCC 8th edition anatomic staging table.\n\n  * If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. If an axillary dissection without sentinel lymph node biopsy is performed to determine nodal status, at least six axillary lymph nodes must be removed and analyzed, and determined to be negative, for the patient to be considered node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H\\&E or immunohistochemistry (IHC) will be considered node-negative.\n  * Any axillary lymph node with tumor clusters between 0.02 and 0.2 cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the principal investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record.\n  * Patients who have an area of a T1aN0, ER+ (defined as \\>10%), HER2-negative cancer in addition to their primary HER2-positive tumor are eligible.\n* HER2-positive by ASCO CAP 2018 guidelines, confirmed by central testing. NOTE: HER-2 status must be confirmed to be positive by central review by NeoGenomics prior to patient starting protocol therapy. Patients previously having had HER2 immunohistochemical testing by NeoGenomics do not need to undergo retesting for central confirmation of HER2 status.\n\nNOTE: DCIS components will not be counted in the determination of HER2 status\n\n* ER\u002FPR determination is required. ER and PR assays should be performed by immunohistochemical methods according to the local institution standard protocol.\n* Bilateral breast cancers that individually meet eligibility criteria are allowed.\n* Patients with multifocal or multicentric disease are eligible, as long as each tumor individually meets eligibility criteria. Central confirmation is needed for any site of disease that is tested to be HER2-positive by local testing (unless testing was previously done by NeoGenomics).\n* Patients with a history of ipsilateral DCIS are eligible if they were treated with wide excision alone, without radiation therapy, or treated with a mastectomy for this current breast cancer. Patients with a history of contralateral DCIS are not eligible.\n* ≤ 90 days between the planned treatment start date and the patient's most recent breast surgery for this breast cancer\n* ≥ 18 years of age with any menopausal status.\n* ECOG Performance Status 0 or 1\n* All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection\n\n  * All margins should be clear of invasive cancer or DCIS (i.e. no tumor on ink). The local pathologist must document negative margins of resection in the pathology report. If all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed. Likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed.\n* Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy. Radiation to the conserved breast is required.\n* Patients may have received up to 4 weeks of tamoxifen therapy, or other hormonal therapy, for adjuvant therapy for this cancer. Patients cannot receive adjuvant hormonal therapy during protocol treatment for the first 12 weeks.\n* Prior oophorectomy for cancer prevention is allowed.\n* Patients who have undergone partial breast radiation (duration ≤ 14 days) prior to registration are eligible. Partial breast radiation must be completed prior to 2 weeks before starting protocol therapy. Patients who have undergone whole breast radiation are not eligible.\n* Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤ 2 weeks) are eligible. Patients must have discontinued the investigational agent at least 14 days before participation.\n* Adequate bone marrow function:\n\n  * ANC ≥ 1000\u002Fmm3,\n  * Hemoglobin ≥ 9 g\u002Fdl\n  * Platelets ≥ 100,000\u002Fmm3\n* Adequate hepatic function:\n\n  * Total bilirubin ≤ 1.2mg\u002FdL\n  * AST and ALT ≤ 1.5x Institutional ULN\n  * For patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range. Serum alkaline phosphatase should be ≤ 1.5x Institutional ULN.\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* Premenopausal patients must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause.\n* Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and\u002For partner. Contraceptive use must be continued for the duration of the study treatment and for 7 months after the last dose of study treatment. Hormonal birth control methods are not permitted.\n* Patients should have tumor tissue available, and a tissue block of sufficient size to make 15 slides, which must be sent to DFCI for correlative research. If a tissue block is unavailable, sites may send one H\\&E-stained slide and 15 unstained sections of paraffin-embedded tissue on uncharged slides. Slide sections should be 4-5 microns in thickness. It is also acceptable to submit 2 cores from a block of invasive tissue using a 1.2 mm diameter coring tool. If tumor is not available, the investigator must document why tissue is not available in the patient medical record, and that efforts have been made to obtain tissue.\n* Willing and able to sign informed consent\n* Must be able to read and understand English in order to participate in the quality of life surveys. If patient does not read and understand English, the patient is still eligible, but cannot participate in the quality of life surveys.\n\nExclusion Criteria:\n\n* Any of the following due to teratogenic potential of the study drugs:\n\n  * Pregnant women\n  * Nursing women\n  * Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDs, surgical sterilization, abstinence, etc.).\n  * Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc.).\n* Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations\u002Fnodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)\n* Patients with a history of previous invasive breast cancer.\n* History of prior chemotherapy in the past 5 years.\n* History of paclitaxel therapy\n* Patients with active liver disease, for example due to hepatitis B virus, hepatitis C virus, autoimmune hepatic disorder, or sclerosing cholangitis\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances:\n\n  * Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.\n  * Individuals with the following cancer are eligible regardless of when they were diagnosed and treated: cervical cancer in situ, and non-melanoma cancer of the skin.\n* Intercurrent illness including, but not limited to: ongoing or active, unresolved systemic infection, renal failure requiring dialysis, active cardiac disease, prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion), history of CHF, current use of any therapy specifically for CHF, uncontrolled hypertension, significant psychiatric illness, or other conditions that in the opinion of the investigator limit compliance with study requirements.",{"count":603,"type":21},500,[24],"This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery.\n\nThe name of the study drugs involved are:\n\n* Trastuzumab-emtansine (T-DM1, Kadcyla)\n* Trastuzumab SC (Herceptin Hylecta)\n* Paclitaxel",[28,27],[28,27],{"date":609,"type":38},"2026-04-24",{"date":611,"type":38},"2021-06-16",{"date":613,"type":21},"2028-05-01",{"name":615,"class":168},"Dana-Farber Cancer Institute",{"id":617,"slug":4,"hasResults":11,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":11,"sex":211,"minAge":18,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":345,"phases":4,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":632,"locationsCount":169},"100555922","NCT06518382","Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in HER2+ Breast Cancer Patients","A Retrospective Observational Study Characterizing Tumour-microenvironment Spatial Interaction Aimed at the Identification of New Markers of Resistance to Therapy in HER2-positive Breast Cancer Patients","Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent for participation in the study.\n2. Patient underwent the following procedure before surgery: biopsy, sequential chemotherapy comprising treatment with antracyclines (AC\u002FEC q21, 4 cycles) followed by taxanes (paclitaxel 1,8,15 q21 for 12 weeks) in combination with the anti-HER2 antibody trastuzumab.\n3. Specimen collected at surgery display residual invasive disease in the breast\u002Flymph node.\n\nExclusion Criteria:\n\n1. pre-existing conditions or concurrent diagnoses;\n2. concomitant use of other medications during neo-adjuvant treatment;\n3. quality of stored specimen does not meet the standard for Imaging Mass Cytometry analysis.",{"count":623,"type":21},10,"This retrospective observational study aims at the comparison of the tumour-microenvironment tissue architecture before and after neo-adjuvant therapy in samples from HER2-positive (HER2+) breast cancer (BrCa) patients that display residual invasive disease in the breast\u002Flymph node at surgery after standard-of-care combined chemotherapy and trastuzumab treatment.\n\nThe working hypothesis of the investigators is that:\n\nTherapy imposes a selective pressure on tumour-microenvironment features promoting resistance to treatment.\n\nParticipant that have already undergone neo-adjuvant treatment as part of their regular medical care for HER2-positive breast cancer will provide access to formalin-fixed paraffin-embedded (FFPE) samples taken before and after therapy.\n\nTumoral, peri-tumoral and stromal regions of each specimen will be analyzed with the ultimate goal to identify new biomarkers (and putative targets) of resistance to therapy.",[27],"2026-04-10",{"date":628,"type":38},"2026-04-15",{"date":630,"type":38},"2024-12-10",{"date":245,"type":21},{"name":633,"class":168},"Giampaolo Bianchini",{"id":635,"slug":4,"hasResults":11,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":4,"eligibilityCriteria":639,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":22,"phases":641,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":655},"100430550","NCT04886531","Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers","An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Cancers Hoosier Cancer Research Network BRE17-141","Inclusion Criteria:\n\nSubject must meet all of the following applicable inclusion criteria to participate in this study:\n\n* Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Age ≥ 18 years at the time of consent.\n* Postmenopausal females. NOTE: Postmenopausal status defined as: prior bilateral oophorectomy, Age ≥ 60 years, or Age \\\u003C 60 years and amenorrhea for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) or an estradiol level in postmenopausal ranges per local reference range.\n* ECOG Performance Status of 0-2 within 28 days prior to registration.\n* Anatomic, clinical stage I-III, invasive breast cancer, greater than 10mm\n* HER2-positive (by the most recent ASCO-CAP criteria)\n* ER positive (≥ 10%). NOTE: There is no requirement for PR status; PR positive or negative allowed.\n* Resectable breast cancer in which pre-operative therapy is appropriate (T \\> 10mm and\u002For node-positive).\n* Archival tissue from the diagnostic pre-treatment biopsy is required. This sample should be identified at screening and shipped by Week 4. If archival tissue is not available, the subject is not eligible for the study.\n* Agreeable to repeat breast biopsy at 3 weeks after initiation of treatment.\n* Candidate for either letrozole or anastrozole, as determined by the treating physician\n* Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) documented within 4 weeks prior to the study treatment.\n* Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.\n\n  * Hematological\n\n    * Platelet count ≥100,000\u002FuL\n    * Absolute Neutrophil Count (ANC) ≥1500\u002FuL\n    * Hemoglobin (Hgb) ≥10 g\u002FdL\n  * Renal\n\n    ---Calculated creatinine clearance: CrCl ≥30 mL\u002Fmin using the Cockcroft-Gault formula\n  * Hepatic\n\n    * Bilirubin ≤1.5 x upper limit of normal (ULN)\n    * Aspartate aminotransferase (AST) ≤ 2.5 × ULN\n    * Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.\n* For patients with known serologic evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial.\n* Ability of the subject to understand and comply with study procedures for the entire length of the study, as determined by the enrolling physician or protocol designee.\n\nExclusion Criteria:\n\nSubjects meeting any of the criteria below may not participate in the study:\n\n* Locally advanced or inflammatory breast cancer. NOTE: Locally advanced is defined as Stage IIIC or greater.\n* Evidence of metastatic disease. Systemic imaging is not required.\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial: exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years.\n* Active infection requiring systemic therapy.\n* Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study (see protocol).\n* Treatment with any investigational drug within 14 days prior to registration or within 5 half-lives of the investigational product, whichever is longer.\n* Subject has had major surgery within 14 days prior to registration or has not recovered from major side effects of the surgery (tumor biopsy is not considered as major surgery).\n* Any impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) or significantly impair the ability to swallow capsules\u002Ftablets.\n* Known history of myelodysplastic syndrome or acute myeloid leukemia.\n* Subjects with any of the following conditions:\n\n  * History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days prior to registration.\n  * Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to registration.\n  * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to registration.\n  * Symptomatic congestive heart failure (New York Heart Association III-IV) or documented current cardiomyopathy with left ventricular ejection fraction (LVEF) \\\u003C50%.\n  * Clinically significant cardiac ventricular arrhythmias (e.g. sustained ventricular tachycardia\u002Fventricular fibrillation) or high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block) unless a pacemaker is in place.\n  * Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.\n* Any concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate subject participation in the clinical study or compromise compliance with the protocol.",{"count":46,"type":21},[24],"Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.",[28,27,644,645],"ER Positive Breast Cancer","PR-Positive Breast Cancer","2026-04-02",{"date":648,"type":38},"2026-04-08",{"date":650,"type":38},"2022-07-21",{"date":652,"type":21},"2027-07-21",{"name":654,"class":168},"Ruth O'Regan",4,{"id":657,"slug":4,"hasResults":11,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":662,"targetDuration":4,"studyType":22,"phases":663,"briefSummary":664,"conditions":665,"keywords":668,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":169},"100632216","NCT07510802","Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC","Phase 1\u002F2, Biomarker-guided, Open-label Study of Allogeneic Dual-target CAR-NK Cells Directed Against HER2\u002FERBB2, MUC1, and\u002For ROR1 in Patients With Advanced or Metastatic Breast Cancer (Including HER2-positive and Triple-negative Disease).","Inclusion Criteria:\n\n* Histologically confirmed breast carcinoma that is locally advanced, unresectable, or metastatic.\n* Disease subtype: HER2-positive breast cancer or triple-negative breast cancer (TNBC).\n* Progression after, intolerance to, or ineligibility for standard therapies appropriate for the disease subtype and line of therapy.\n* At least one measurable lesion per RECIST v1.1.\n* Tumor antigen assessment available (fresh or archival): expression of at least one candidate target antigen (HER2\u002FERBB2, MUC1, or ROR1). For TNBC, mesothelin assessment may be performed for exploratory analyses.\n* ECOG performance status 0-1.\n* Adequate organ function (example thresholds): ANC ≥ 1.0 x 10\\^9\u002FL; platelets ≥ 75 x 10\\^9\u002FL; hemoglobin\n\n  * 8 g\u002FdL; AST\u002FALT ≤ 3x ULN (≤ 5x with liver metastases); total bilirubin ≤ 1.5x ULN; creatinine clearance\n  * 50 mL\u002Fmin.\n* Left ventricular ejection fraction (LVEF) ≥ 45% and no uncontrolled cardiac arrhythmia.\n* Negative pregnancy test for participants of childbearing potential; agreement to use effective contraception during study treatment and for 6 months after last CAR-NK infusion.\n* Ability to understand and willingness to sign informed consent.\n\nExclusion Criteria:\n\n* Active, untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients with treated CNS metastases may be eligible if clinically stable for ≥ 4 weeks and off high-dose steroids.\n* Prior gene-modified cellular therapy (e.g., CAR-T or CAR-NK) within 6 months or unresolved grade ≥ 2 toxicity from prior cellular therapy.\n* Clinically significant active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted).\n* Uncontrolled infection, including uncontrolled HBV, HCV, or HIV infection (controlled infections may be eligible per investigator).\n* History of severe hypersensitivity to fludarabine or cyclophosphamide.\n* Pregnant or breastfeeding.\n* Concurrent participation in another interventional study that could confound safety or efficacy assessments.\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for the study (e.g., uncontrolled comorbidity, inability to comply with protocol procedures).",{"count":450,"type":21},[80,24],"This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer. After a tumor antigen assessment (HER2\u002FERBB2, MUC1, ROR1,TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.",[666,27,667],"Breast Cancer (Advanced\u002FMetastatic)","Triple-negative Breast Cancer",[669,670,671,672,673,674,675,676,677,678,679,680],"CAR-NK","Dual targeting","Adoptive cellular immunotherapy","HER2 (ERBB2)","MUC1","ROR1","Mesothelin","Solid tumor","Biomarker-guided cohort assignment","Lymphodepletion","Fludarabine","Cyclophosphamide","2026-03-31",{"date":683,"type":38},"2026-04-06",{"date":685,"type":38},"2026-02-02",{"date":687,"type":21},"2028-04-17",{"name":689,"class":45},"Beijing Biotech",""]