[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"invasive-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:invasive-breast-cancer":418},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,44,73,95,150,182,205,230,258,285,323,348,376,396],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":43},"100470927",false,"NCT05412225","A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer","Feasibility of Preoperative Radiotherapy in T3 and T4 Breast Cancer Patients Who Are Responders to Neoadjuvant Chemotherapy to Allow for Immediate Reconstruction: a Prospective Study","Inclusion Criteria:\n\n* Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer\n* cT3-4 cN0-3 tumor\n* Partial or complete response to NAC on imaging and clinical examination using the Response Evaluation Criteria in Solid Tumors (RECISTv1.1) definition.\n* Desire to undergo autologous reconstruction and assessed to be an appropriate candidate by a plastic and reconstructive surgeon\n* Able to read and understand English\n\nExclusion Criteria:\n\n* Prior ipsilateral breast cancer\n* Bilateral breast cancer\n* Pregnant\n* Stage IV disease at presentation\n* Stable disease or progressive disease after NAC\n* Surgically unresectable breast disease\n* BMI \\>40\n* Prior history of thoracic radiotherapy","FEMALE","18 Years",{"count":18,"type":19},60,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","The purpose of this study to test an alternative treatment approach that involves giving participants radiotherapy before their mastectomy (preoperative radiotherapy) and performing immediate reconstruction surgery at the time of mastectomy. The immediate reconstruction surgery is called an immediate autologous reconstruction (IR) and is different than the standard reconstruction surgery people with T4 breast cancer have. IR is a surgical procedure where immediately following your mastectomy, the surgeon takes tissue from another part of your body and uses it to re-create your breast. The standard reconstruction surgery occurs later and can be done with an implant or tissue from your body.\n\nThe main purpose of this study to find out if the alternative treatment approach shown above is feasible. The study will see how safe this alternative treatment approach is compared with the standard treatment approach.",[25,26],"Breast Cancer","Invasive Breast Cancer",[28,29,30,31],"breast cancer","mastectomy","Memorial Sloan Kettering Cancer Center","22-136","RECRUITING","2026-07-01",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":36},"2022-06-06",{"date":40,"type":19},"2027-06-06",{"name":30,"class":42},"OTHER",7,{"id":45,"slug":4,"hasResults":10,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":10,"sex":51,"minAge":16,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100380170","NCT04230109","Sacituzumab Govitecan In TNBC","A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)","NeoSTAR","Inclusion Criteria:\n\n* Female or male patients ≥ 18 years of age.\n* Histologically confirmed diagnosis of invasive breast cancer, previously untreated.\n* Participants must have biopsy proven ER negative (ER-), PR negative (PR-), HER2 negative (HER2-), invasive breast cancer. ER, PR, and HER2 positivity would be determined per ASCO\u002FCAP guidelines by institutional (local) assessment. Patients with multi-focal and multicentric disease are eligible provided all histologically examined lesions are ER-\u002FPR-\u002FHER2- (local assessment). The need to biopsy additional lesions is at the discretion of the treating physician. Patients with bilateral invasive breast cancer are eligible provided all histologically examined lesions are ER-\u002FPR-\u002FHER2- (local assessment).\n* Primary tumor (at least one lesion) 1 cm or greater measured by radiological imaging. Regional lymph node AJCC (v7) TNM stages N0-N2. If node positive, any primary tumor size is permissible. Absence of distant metastatic disease (AJCC TNM stage M0). Staging scans are not required and are per discretion of the treating physician.\n* Pre- and postmenopausal women are eligible.\n* ECOG performance status = 0, 1 (Karnofsky ≥60%, see Appendix A)\n* Ability to understand and the willingness to sign a written informed consent form (ICF). Patient has signed the ICF prior to any screening procedures being performed and is able to comply with protocol requirements, including research biopsy.\n* Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening:\n* Absolute neutrophil count (ANC) ≥ 1,500 per mm3\n* Platelets ≥ 100,000 per mm3\n* Hemoglobin ≥9.0 g\u002FdL\n* INR ≤1.5\n* Serum creatinine \\\u003C1.5 mg\u002FdL or creatinine clearance ≥50 mL\u002Fmin\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5 x ULN.\n* Total bilirubin ≤1.5 x ULN or in patients with well-documented Gilbert's Syndrome direct bilirubin ≤1.5 x ULN.\n\nExclusion Criteria:\n\n* Inflammatory breast cancer, or locally recurrent breast cancer\n* Participants currently receiving systemic therapy for any other malignancy or having received systemic therapy for a malignancy in the preceding 3 years.\n* Uncontrolled inter-current 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.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac reppolarization abnormality including any of the following:\n\n  * History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry.\n  * History of cardiac failure, known cardiomyopathy (LVEF \\\u003C 50%; new LVEF assessment is not specifically required for this trial), significant\u002Fsymptomatic bradycardia, Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following:\n* Known risk to prolong the QT interval or induce Torsade's de Pointes.\n* Uncorrected hypomagnesemia or hypokalemia.\n* Systolic Blood Pressure (SBP) \\>160 mmHg or \\\u003C90 mmHg.\n* Bradycardia (heart rate \\\u003C50 at rest), by ECG or pulse. On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF \\>470 screening ECG\n* Pregnant or breast-feeding women are excluded from this study because the safety of study medications is not established.\n* Known HIV-positive participants on combination antiretroviral therapy are ineligible.\n* These participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Separate HIV testing for this trial is not required. Similarly, separate Hepatitis B or C testing for this trial is not required, but patients with known (or history) of hepatitis B positive, or hepatitis C positive infection will be excluded","ALL",{"count":53,"type":19},260,[55],"PHASE2","This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC)\n\nThe names of the study drugs involved in this study is:\n\n* Sacituzumab govitecan (SG)\n* Pembrolizumab (combination therapy with SG)",[26,58,59,60,61],"Triple Negative Breast Cancer","ER-Negative Breast Cancer","PR-Negative Breast Cancer","HER2-negative Breast Cancer",[26,58,59,60,61],"2026-05-29",{"date":65,"type":36},"2026-06-02",{"date":67,"type":36},"2020-07-14",{"date":69,"type":19},"2029-10",{"name":71,"class":42},"Massachusetts General Hospital",5,{"id":74,"slug":4,"hasResults":10,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":10,"sex":51,"minAge":16,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":20,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100414530","NCT04677816","Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients","Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients Receiving Neoadjuvant Chemotherapy for Operable Triple Negative Breast Cancer","Inclusion Criteria:\n\n* Women or men with histologically confirmed invasive mammary carcinoma.\n* Known triple negative ER\u002FPR\u002FHER2 receptor status as defined by:\n\n  * ER and PR less than or equal to 10% and\n  * HER2 negative based on one of the following:\n  * IHC 0 or 1+\n  * IHC 2+ and FISH negative\n  * IHC 2+ and FISH equivocal and no indication for HER2 targeted therapy based on the treating investigators discretion (i.e., HER2: CEP17 ratio \\\u003C 2.0 or HER2 total copy number \\\u003C6)\n* Patients who plan to undergo neoadjuvant chemotherapy prior to definitive surgical management. Participants are eligible up to 2 weeks after initiating neoadjuvant chemotherapy.\n* ECOG performance status of 0, 1 or 2.\n* Age ≥ 18.\n* The effects of high dose vitamin D on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).\n\nExclusion Criteria:\n\n* Patients with nephrolithiasis within the past year.\n* Patients with known sarcoidosis.\n* Patients with corrected calcium \\>10.5 mg\u002FdL within 30 days prior to initiation of chemotherapy.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to vitamin D.\n* Pregnant women are excluded from this study because vitamin D supplementation greater than the recommended daily allowance (RDA) is a pregnancy class C agent with no adequate or well controlled studies in humans.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with high dose vitamin D (greater than RDA), women who are breastfeeding are excluded from this study.\n* Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry.\n* Patients currently taking Vitamin D at a dose of 50,000 International Units (IU) once weekly.",{"count":80,"type":19},50,[55],"A two arm pilot study investigating the rate of pathologic complete response in patients with vitamin D deficiency and triple negative breast cancer undergoing standard neoadjuvant chemotherapy + vitamin D supplementation, including an observational arm to describe response in patients who are not deficient. Investigators hypothesize that vitamin D supplementation during neoadjuvant chemotherapy in operable triple negative breast cancer patients with vitamin D deficiency, will increase the rate of pathologic complete response chain reaction to that of vitamin D sufficient patients based on historical controls.",[58,84,26],"Vitamin D Deficiency","2026-04-09",{"date":87,"type":36},"2026-04-14",{"date":89,"type":36},"2021-10-22",{"date":91,"type":19},"2026-08",{"name":93,"class":42},"Wake Forest University Health Sciences",1,{"id":96,"slug":4,"hasResults":10,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":10,"sex":51,"minAge":16,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":20,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":94},"100536733","NCT06268665","Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","Inclusion Criteria:\n\n* Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria.\n* Must be planning to receive paclitaxel weekly for 12 weeks (12 weeks total) as part of neoadjuvant, adjuvant, or metastatic cancer treatment.\n\n  * Concurrent biologic therapy (e.g., trastuzumab and pertuzumab) is allowed.\n  * Currently receiving hormone therapy, bisphosphonates, denosumab or LHRH-agonists is allowed.\n  * Concurrent use of immune checkpoint inhibitor therapy is allowed.\n  * (Neo)adjuvant chemotherapy with doxorubicin and cyclophosphamide is allowed.\n  * Concurrent use of carboplatin with weekly paclitaxel in the study is allowed.\n* May participate concurrently in other cancer trials.\n* Must be able to complete questionnaires in English or Spanish.\n* Age ≥ 18 years old at the time of consent.\n* ECOG performance status of 0 - 1 (Karnofsky scale ≥ 70%, see Appendix).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Individuals of child-bearing potential must agree to use birth control (e.g., hormonal or barrier method; abstinence, an intrauterine device) prior - to study entry, for the duration of study participation (including dose interruptions), and for 3 months after the last dose of tart cherry juice supplement; or be surgically sterilized (e.g., hysterectomy or tubal ligation).\n* Patients with known human immunodeficiency virus (HIV) are allowed in the study, but HIV-positive patients must have:\n\n  * A stable regimen of highly active anti-retroviral therapy (HAART)\n  * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n  * A CD4 count above 250 cells\u002FµL and an undetectable HIV viral load on standard PCR-based tests within the last year.\n* Stated willingness to not drink any additional tart cherry or any cherry juice while on the study.\n* Ability and willingness to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Have received any prior therapy with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum. Doxorubicin is allowed (≥ 2 week washout period required).\n* Active or history of peripheral neuropathy, or any chronic diseases associated with peripheral neuropathy such as diabetes mellitus, alcohol use disorder, or systemic lupus erythematosus.\n* Currently taking anticoagulant medication.\n* Currently taking Vitamin E, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline or duloxetine. If a patient is taking any of these supplements\u002Fmedications, they must agree to stop at the time of registration. Multivitamins containing Vitamin E are allowed, however Vitamin E \\> 1,000 international units (IU) must be discontinued at the time of registration.\n* Patients may not use cold therapy gloves for chemotherapy induced neuropathy.\n* Known allergy to cherries.\n* Inability to swallow liquid.\n* Pregnant or breastfeeding individuals (lactating individuals must agree not to breast feed while taking study juice supplementation).\n* Any condition that would prohibit the understanding or rendering of informed consent.\n* Any condition that in the opinion of the investigator would interfere with safety or compliance while on trial.",{"count":102,"type":19},86,[55],"This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.\n\nEligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).",[25,106,107,108,109,26,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140],"Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III","Breast Cancer Stage IV","Ovarian Cancer","Ovarian Cancer Stage 1","Ovarian Cancer Stage II","Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Ovarian Cancer Stage IA","Ovarian Cancer Stage IB","Ovarian Cancer Stage IC","Ovarian Cancer Stage 2","Ovarian Cancer Stage 3","Ovarian Cancer Stage IIIb","Ovarian Cancer Stage IIIC","Breast Cancer Stage IIIA","Breast Cancer Invasive","Breast Cancer, Stage IA","Breast Cancer, Stage IB","Breast Cancer Stage IIA","Breast Cancer Stage IIB","Breast Cancer Stage IIIB","Breast Cancer Stage IIIc","Cancer, Breast","Tumors, Breast","Mammary Cancer","Mammary Carcinoma","Breast Carcinoma","Breast Neoplasm","Malignant Breast Neoplasm","Malignant Tumor of Breast","Cancer of Ovary","Ovary Cancer","Ovary Neoplasm","2026-03-02",{"date":143,"type":36},"2026-03-04",{"date":145,"type":36},"2024-08-15",{"date":147,"type":19},"2027-12",{"name":149,"class":42},"University of California, Davis",{"id":151,"slug":4,"hasResults":10,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":10,"sex":51,"minAge":16,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":20,"phases":159,"briefSummary":161,"conditions":162,"keywords":168,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100390804","NCT04368702","CONFIRM: Magnetic Resonance Guided Radiation Therapy","Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol","CONFIRM","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed malignancy requiring radiation\n* Age 18 years of older\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Any further criteria listed in the specific disease site cohort\n\nExclusion Criteria\n\n* History of allergic reactions attributed to gadolinium-based IV contrast\n\n  \\-- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility\n* Severe claustrophobia or anxiety\n* Participants who cannot undergo an MRI\n* Any other exclusion criteria listed in the specific disease site cohort",{"count":158,"type":19},70,[160],"NA","This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.",[163,26,164,165,166,167],"Gastric Cancer","in Situ Breast Cancer","Mantle Cell Lymphoma","Larynx Cancer","Bladder Cancer",[163,26,164,169,170,171],"Lymphoma","Larynx","Bladder","2026-02-05",{"date":174,"type":36},"2026-02-09",{"date":176,"type":36},"2021-05-01",{"date":178,"type":19},"2029-06-18",{"name":180,"class":42},"Brigham and Women's Hospital",2,{"id":183,"slug":4,"hasResults":10,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":10,"sex":51,"minAge":16,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":20,"phases":191,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":94},"100541331","NCT06328465","fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases","fREEDOM","Inclusion Criteria:\n\n* Pre or post-menopausal patient with histologically confirmed invasive breast cancer stage II - III HER2 + or TN operated breast carcinoma or patients underwent neoadjuvant treatment (included cT4d) with residual disease at definitive surgery\n* No evidence of distant metastases at baseline perioperative radiological staging (DWB-MRI, total body Computed Tomography (CT) or Positron Emission Tomography (PET\u002FCT) must be performed +\u002F- 1 month from surgery)\n* No relevant comorbidities\n* Eastern Cooperative Oncology Group (ECOG) performance status 0\n* Geographically accessible for follow up\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Absolute contraindications that exclude the execution of the MRI investigation, regardless of the clinical indication\n* Relative contraindications that include situations in which the innocuousness of the examination is not documented with certainty that therefore do not recommend the execution, except for serious indications related to the patient's clinical need\n* Older age (\\>75 years)\n* Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix\n* Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","75 Years",{"count":190,"type":19},145,[160],"The aim of this study is to understand whether DWB-MRI (Diffusion Whole Body-Magnetic Resonance Imaging) is useful for early detection of locoregional or distant recurrence and whether early diagnosis influences the prognosis in high-risk populations thanks to the possibility of being able to use a more effective treatment. The primary objective is to evaluate 5-year overall survival (OS) in patients with Human Epidermal Growth Factor Receptor 2 positive (HER2+) or high-risk Triple Negative (TN) undergoing surveillance with DWB-MRI.",[26,194,58],"HER2-positive Breast Cancer",[26,194,58],"2026-01-02",{"date":198,"type":36},"2026-01-06",{"date":200,"type":36},"2019-11-22",{"date":202,"type":19},"2028-12-31",{"name":204,"class":42},"European Institute of Oncology",{"id":206,"slug":4,"hasResults":10,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":94},"100612946","NCT07260188","Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy","Prospective Multicenter Study on the Collection of Tumor Biopsies and the Generation of Organoids Derived From Breast Cancer Patients Scheduled for Neoadjuvant Chemotherapy","PDO-Neo01","Inclusion Criteria:\n\n* Female subjects;\n* Confirmed diagnosis of breast heteroplasia\n* Age 1\\>= 8 years;\n* Indication for neoadjuvant chemotherapy;\n* Patients willing to follow the usual oncological follow-up;\n* Patients with de novo metastatic disease (M+), receiving primary chemotherapy, if candidates for primary tumor biopsy;\n* Subjects who agree to participate in the study by signing and dating the Informed Consent form.\n\nExclusion Criteria:\n\n* Patients who have already undergone prior chemotherapy treatments;\n* Patients without a proven cyto-histological diagnosis of breast carcinoma;\n* Subjects affected by other solid tumors besides the breast lesion.",{"count":213,"type":19},240,"OBSERVATIONAL","The aim of this study is to establish patient-derived organoid (PDO) and tumor tissue cultures from breast cancer patients, in order to create personalized, accurate, and reliable preclinical models capable of providing information on the diverse biomolecular portraits of breast cancer. These models may also be used to predict the achievement of pathological complete response after neoadjuvant chemotherapy (NAC) treatment, study the biological, molecular, genetic, and microenvironmental characteristics of each tumor, and isolate tumor-derived extracellular vesicles from the PDOs and tissues and analyze them as potential biomarkers of response to NAC.",[26],[58,218,219,220],"Neadjuvant Chemotherapy","Patient-Derived Organoids","Liquid Biopsy","2025-11-28",{"date":223,"type":36},"2025-12-03",{"date":225,"type":36},"2025-09-23",{"date":227,"type":19},"2028-07",{"name":229,"class":42},"Istituti Clinici Scientifici Maugeri SpA",{"id":231,"slug":4,"hasResults":10,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":10,"sex":51,"minAge":16,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":94},"100368239","NCT04074720","Prospective Breast Cancer Biospecimen Collection","Inclusion Criteria:\n\n* Adults \\>18 years old at time of consent\n* Subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf.\n* Patients with carcinoma in situ or invasive breast cancer\n* Patient must be undergoing one of the following:\n\n  * definitive surgical tumor resection for breast cancer OR\n  * placement of a vascular access device as a prelude to neoadjuvant therapy for breast cancer OR\n  * neurosurgical resection of a brain metastasis from primary breast cancer.\n\nExclusion Criteria:\n\n* \\\u003C18 years old\n* Not able to give informed consent and does not have acceptable surrogate capable to giving informed consent.\n* Active drug\u002Falcohol dependence or abuse history",{"count":236,"type":19},200,"Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and\u002For death",[25,26,239],"Carcinoma in Situ of the Breast",[25,241,242,243,244,245,246,247,248,249],"Tumor Tissue Collection","Serum Collection","Plasma Collection","Fresh Tissue Collection","Fixed Tissue Collection","Translational Research","Biospecimen Collection","Surgical Resection","Vascular Access Placement","2025-11-25",{"date":223,"type":36},{"date":253,"type":36},"2018-05-10",{"date":255,"type":19},"2028-07-01",{"name":257,"class":42},"Thomas Jefferson University",{"id":259,"slug":4,"hasResults":10,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":10,"sex":51,"minAge":16,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":20,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"100405007","NCT04553770","Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer","A Phase II, Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan (DS-8201a) With or Without Anastrozole for HER2 Low Hormone Receptor Positive (HR+) Breast Cancer in the Neoadjuvant Setting","Inclusion Criteria:\n\n* Previously untreated operable invasive carcinoma of the breast greater than 2.0 cm (cT2) in size based on physical exam or imaging. Patients with clinical node negative disease or clinical node (cN1\u002FcN2) positive are allowed provided they are deemed to have operable disease at study entry\n* Participants with clinically involved lymph nodes should not have radiological evidence of distant disease per standard of care staging prior to patient informed consent form (PICF) signature\n* In the United States\n* Tumor is HER2-low by immunohistochemistry (IHC), defined as 1+ or 2+, confirmed by central testing (central testing results not required for enrollment, unless no local results available). If HER2 is 2+ by IHC, fluorescence in situ hybridization (FISH) must be performed (per standard of care) and the FISH result must be HER2 non-amplified per 2018 American Society of Clinical Oncology College of American Pathologists (ASCO CAP) guidelines\n* Tumor is HR positive (HR+) per ASCO CAP guidelines with known estrogen and progesterone receptor status, locally defined\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Normal cardiac function (left ventricular ejection fraction \\[LVEF\\] \\>= 50%) based on echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization\u002Fenrollment\n* Platelet count \\>= 100 000\u002Fmm\\^3 (Platelet transfusion is not allowed within 1 week prior to screening assessment) (within 14 days before randomization\u002Fenrollment)\n* Hemoglobin \\>= 9.0 g\u002FdL (red blood cell transfusion is not allowed within 1 week prior to screening assessment) (within 14 days before randomization\u002Fenrollment)\n* Absolute neutrophil count (ANC) \\>=1500\u002Fmm\\^3 (Granulocyte colony-stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment) (within 14 days before randomization\u002Fenrollment)\n* Creatinine clearance \\>= 30 mL\u002Fmin as calculated using the Cockcroft-Gault equation or serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) (within 14 days before randomization\u002Fenrollment)\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 3 x ULN (within 14 days before randomization\u002Fenrollment)\n* Total bilirubin =\\\u003C 1.5 x ULN (within 14 days of randomization\u002Fenrollment). Participants with Gilbert's syndrome with a total bilirubin =\\\u003C 2.0 times ULN and direct bilirubin within normal limits are permitted\n* Serum albumin \\>= 2.5 g\u002FdL (within 14 days before randomization\u002Fenrollment)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (within 14 days before randomization\u002Fenrollment)\n* Has adequate treatment washout period before randomization\u002Fenrollment, defined as:\n\n  * Major surgery \\>= 4 weeks\n  * Chloroquine\u002Fhydroxychloroquine \\> 14 days\n* Negative pregnancy test (serum) for women of child bearing potential (CBP):\n\n  * Women are considered of CBP unless: they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment she is considered not of CBP\n* Male and female participants of reproductive\u002Fchildbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Highly effective contraception methods include:\n\n  * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n  * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking trial treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n  * Male partner sterilization (at least 6 months prior to randomization). For female patients on the trial the vasectomized male partner should be the sole partner for that patient. If vasectomy of the male partner is the highly effective method of contraception chosen, the success of the vasectomy should be medically confirmed according to local practice\n  * Placement of an intrauterine device (IUD)\n* Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrollment in this study\n* Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Estradiol level must be in post-menopausal range per local lab interpretation prior to baseline biopsy\n\n  * Postmenopausal status is defined as:\n\n    * Patient underwent bilateral oophorectomy, or\n    * Age \\>= 60 years, or\n    * Age \\\u003C 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) and follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges\n  * Note: for women with therapy-induced amenorrhea, serial measurements of FSH and\u002For estradiol per local clinical guidelines are required for determination of postmenopausal status. All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial\n* Pre- or peri-menopausal and amenable to being treated with ovarian function suppression drugs (goserelin, leuprolide, or triptorelin) per standard of care. Patients must have started treatment with ovarian function suppression at least 28 days prior to first dose of study treatment\n\nExclusion Criteria:\n\n* Recurrent or metastatic breast cancer\n* Bilateral breast cancer (multifocal or multicentric breast cancer is allowed provided that all biopsied lesions are HER2 1+ or 2+, not FISH amplified and are HR positive per ASCO guidelines)\n* Inflammatory breast cancer\n* Prior systemic therapy for invasive cancer\n\n  * Prior tamoxifen for history of ductal breast carcinoma in situ (DCIS) allowed, but no prior aromatase inhibitor, no prior chemotherapy and no prior HER2-targeted therapy\n* Prior ipsilateral chest wall radiation\n* Major surgery \\\u003C 4 weeks prior to enrollment\n* Medical history of myocardial infarction within 6 months before randomization\u002Fenrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to randomization\n* Unable to swallow oral medications\n* Is pregnant or lactating, or planning to become pregnant\n* Corrected QT interval prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram\n* Known hypercoaguable disorder requiring use of anticoagulant\n* Significant gastrointestinal disorders limiting absorption or tolerance of oral medications (for example, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Has multiple primary malignancies within 3 years, except:\n\n  * Adequately resected non-melanoma skin cancer\n  * Curatively treated non breast in-situ disease, and other solid non-breast tumors curatively treated are allowed if \\> 3 years from diagnosis and no evidence of recurrence in that time\n  * Prior history of DCIS is allowed as long as patient has not received an aromatase inhibitor, has not received ipsilateral breast\u002Fchest radiation\n  * Prior history of contralateral invasive breast cancer (diagnosed by biopsy \\> 2 years prior to current diagnosis) is allowed provided patient has not received prior aromatase inhibitor, CDK4\u002F6 inhibitor (CDK4\u002F6i), HER2-targeted therapy or chemotherapy and has not experienced any recurrence and has no evidence of recurrence (based on standard clinical evaluation)\n* Other concurrent anti-cancer therapy. Note: ovarian function suppression drugs (goserelin, leuprolide, or triptorelin) and\u002For bone modifying agents (bisphosphonates, denosumab) do not count as anti-cancer therapy for this criteria. If taking bisphosphonates or denosumab, must have been on these agents prior to signing consent\n* Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results\n* Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Subjects should be tested for HIV prior to randomization\u002Fenrollment if required by local regulations or Institutional Review Board (IRB)\u002Fethics committee (EC)\n* Have personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest\n* Have received an autologous or allogeneic stem-cell transplant\n* Has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]). Screening is not required for enrollment\n* Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to first baseline biopsy\n* Has history of severe hypersensitivity reactions to other monoclonal antibodies and\u002For to either the drug substances or inactive ingredients in the drug product\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (i.e. rheumatoid arthritis, Sjogren's, sarcoidosis etc.), or prior pneumonectomy\n* Life expectancy \\\u003C 3 months",{"count":265,"type":19},88,[55],"This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole.",[269,270,26,271,272,273,274],"Early-stage Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Stage II Breast Cancer","Stage IIA Breast Cancer","Stage IIB Breast Cancer","Stage III Breast Cancer","2025-11-06",{"date":277,"type":36},"2025-11-10",{"date":279,"type":36},"2020-10-09",{"date":281,"type":19},"2026-12-31",{"name":283,"class":42},"Jonsson Comprehensive Cancer Center",9,{"id":286,"slug":4,"hasResults":10,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":20,"phases":294,"briefSummary":295,"conditions":296,"keywords":299,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":322},"100485894","NCT05607004","(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+\u002FHER2- Breast Cancer","A Phase 2 Trial of (Z)-Endoxifen + Goserelin as Neoadjuvant Treatment for Premenopausal Women With ER+, HER2-, Breast Cancer","EVANGELINE","Inclusion Criteria:\n\n1. Female sex assigned at birth. Female to male transgender individuals who have not had any hormonal therapy may be considered for the trial after review and approval from the medical monitor and study sponsor.\n2. Age 18 years or older\n3. Not lactating, pregnant, or planning to become pregnant in the next year and agrees to take adequate steps to prevent becoming pregnant beginning at informed consent, during treatment and for 9 months after last dose and agree to not breast feed during treatment and for 3 months after last dose.\n4. Must agree to use at least one non-hormonal highly effective method of contraception for the entire duration of study participation beginning at informed consent. Highly effective methods of birth control are defined as those, alone or in combination, that resulted in a low failure rate of \\\u003C1% per year when used consistently and correctly such as intrauterine devices (IUDs, non-hormonal such as copper IUD), bilateral tubal occlusion, sexual abstinence or vasectomized partner\n5. Premenopausal defined as any female who:\n\n   1. is menstruating or\n   2. is not menstruating (last menstrual period \\> 3 months prior to registration) but has a plasma estradiol in the premenopausal range as assessed locally\n6. Pathologic confirmation of strongly estrogen receptor positive (ER+) (defined as estrogen receptor \\[ER\\] ≥ 67% or Allred Score 6-8) by local institution protocol\n7. Eastern Cooperative Oncology Group ECOG Performance Status (ECOG PS) of 0 to 2\n8. Nottingham (Elston-Ellis) Grade 1 or 2\n9. HER2- breast cancer (histologically confirmed) using American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines\n10. Clinical T2 or T3 invasive breast cancer (per American Joint Committee on Cancer \\[AJCC\\] 8th edition clinical staging)\n11. Clinical N0 or N1 invasive breast cancer (per American Joint Committee on Cancer \\[AJCC\\] 8th edition clinical staging)\n12. MRI ≤ 35 days of registration\n13. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects\n14. Willing to provide blood and breast tissue samples for research purposes at specified timepoints for the duration of their participation in the trial.\n\nExclusion Criteria:\n\n1. Bilateral invasive breast cancer; Inflammatory breast cancer defined as clinically significant erythema of the breast and\u002For documented dermal lymphatic invasion or bilateral invasive breast cancer (patients with pre-malignant disease or DCIS\u002FLCIS in contralateral breast are eligible)\n2. Prior diagnosis or treatment for breast cancer, including carcinoma in situ, or history of any other active malignancy within the past 2 years prior to study entry with the exception of:\n\n   1. Adequately treated in situ carcinoma of the cervix uteri\n   2. Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin\n   3. Any other malignancy with a life expectancy of less than 2 years\n3. Any uncontrolled intercurrent illness including, but not limited to:\n\n   1. Ongoing or active infection requiring systemic treatment with strong inhibitors\u002Finducers of CYP450 enzymes (including bacterial infection, fungal infection, or detectable viral infection).\n   2. Symptomatic congestive heart failure,\n   3. Unstable angina pectoris,\n   4. Uncontrolled symptomatic cardiac arrhythmias\n   5. Uncontrolled hypertension\n   6. Uncontrolled diabetes (Hemoglobin A1c \\[HbA1c\\] \\>7%)\n   7. Marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\> 470 milliseconds \\[msec\\]) using Fridericia's QT correction formula seen ≤ 28 days of registration\n4. Any of the following co-morbid conditions:\n\n   1. Known cataracts or retinopathy\n   2. History of deep vein thrombosis (DVT)\u002Fpulmonary embolism (PE)\n   3. Known activated protein C (APC) resistance, an inherited coagulation disorder\n   4. End stage kidney disease requiring dialysis\n5. Evidence of the following laboratory abnormalities ≤ 28 days prior to registration:\n\n   1. Total bilirubin ≥ 1.5 x upper limit of normal (ULN)\n   2. Aspartate aminotransferase (AST) or alanine amino transferase (ALT) ≥ 2.5 x ULN\n   3. Platelet count (PLT) ≤ 75,000\u002Fmm3\n   4. Hemoglobin (Hb) ≤ 10 g\u002FdL\n6. Hormonal therapies including birth control and hormone replacement therapy, or prior use of androgen-based therapy during the study or within 1 week of registration. If subject has a prior medical history of Depo-Provera®, it is recommended that the last dose of 3-month contraceptive agents are \\> 2.5 months from registration.\n7. Allergy to endoxifen, goserelin, or exemestane or any of their components\n8. Participation in another investigational clinical trial ≤ 6 months of registration\n9. Known metastatic disease",{"count":293,"type":19},87,[55],"This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+\u002FHER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or \"SERM\", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.\n\nThe PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50\u002F50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it.\n\nThe Treatment Cohort has been simplified to a single study arm (Z)-endoxifen + goserelin. Up to 20 participants will be enrolled that have a baseline Ki-67 ≤ 10% and 45 participants will be enrolled that have a baseline Ki-67\\>10%.\n\nA key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery.\n\nStudy participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit.",[297,26,298,61],"Breast Neoplasms","Estrogen-receptor-positive Breast Cancer",[28,300,301,302,303,304,305,306,307,308,309,310,311],"ER+\u002FHER2-","endocrine therapy","neoadjuvant","(Z)-endoxifen","exemestane","goserelin","Ki-67","estrogen receptor negative","human epidermal growth factor receptor 2 negative","Stage II","tamoxifen","PKCB1","2025-10-29",{"date":314,"type":36},"2025-10-30",{"date":316,"type":36},"2023-02-14",{"date":318,"type":19},"2027-04",{"name":320,"class":321},"Atossa Therapeutics, Inc.","INDUSTRY",15,{"id":324,"slug":4,"hasResults":10,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":20,"phases":332,"briefSummary":333,"conditions":334,"keywords":337,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":347},"100500349","NCT05795101","TRUDI: TDXD+Durva in HER2+\u002FLow IBC","TRUDI: A Phase II Study of Neoadjuvant Trastuzumab Deruxtecan and Durvalumab for Stage III, HER2-expressing Inflammatory Breast Cancer","TRUDI","Inclusion Criteria:\n\n* Participants must have a histological or cytological diagnosis of invasive breast cancer.\n* All histologic subtypes are eligible.\n* Participants must have a clinical diagnosis of stage III inflammatory breast cancer within the past 6 months\n* HER2-positive status as determined locally by the current ASCO\u002FCAP guidelines or HER2-low tumor expression (IHC 2+\u002FISH-, IHC 1+\u002FISH-, or IHC 1+\u002FISH untested) (note: ISH may be determined by either fluorescence in situ hybridization \\[FISH\\] or dual in situ hybridization \\[DISH\\])\n* Any ER and PR expressions are permitted but must be known\n* Participants must be treatment-naïve\n* Participants must agree to undergo two research biopsies of the tumor (if safely accessible, as determined by the treating investigator): at baseline (prior to the first treatment) and after the first week of treatment on C1D8. Previously collected archival tissue will also be obtained on all participants. For participants for whom the tumor is not safely accessible, this archival tissue needs to be located and availability confirmed at time of registration.\n* Pre- and postmenopausal women or male patients ≥ 18 years of age\n* ECOG performance status 0-1 (Karnofsky \\> 60%, see Appendix A).\n* LVEF ≥ 50% within 28 days prior to enrollment\n* Participants must have normal organ and marrow function prior to enrollment as defined below:\n\n  * Absolute neutrophil count ≥2,000\u002FmcL\n  * Platelets ≥100,000\u002FmcL\n  * Hemoglobin ≥ 9.0 g\u002Fdl\n  * INR\u002FPT\u002FaPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is in therapeutic range of anticoagulant\n  * Total bilirubin ≤1.5 × institutional upper limit of normal (ULN)(or ≤2.0 x ULN in patients with documented Gilbert's Syndrome)\n  * AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN\n  * Serum creatinine ≤1.5 × institutional ULN OR creatinine clearance ≥ 30 mL\u002Fmin\u002F 1.73m2 for participants with creatinine levels above institutional ULN.\n  * Serum albumin ≥2.5 g\u002FdL\n  * International normalized ratio (INR)\u002Fprothrombin time (PT) and either partial thromboplastin or activated partial thromboplastin time (aPTT) ≤1.5 × ULN\n* Women of childbearing potential (WOCBP) and WOCBP who are partners of male participants must agree to use one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception for the duration of study treatment with durvalumab and 7 months after the last dose of study treatment\n* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with durvalumab and 4 months after the last dose of study treatment\n* Must have a life expectancy of at least 12 weeks\n* Body weight \\>30 kg\n* The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* Has received prior systemic anti-cancer therapy for the current diagnosis of inflammatory breast cancer, including chemotherapy, immunotherapy, or targeted therapy\n* Has received any radiotherapy or surgery for the current diagnosis of inflammatory breast cancer. Tumor biopsies are not considered surgery for the purpose of enrollment.\n* Prior hypersensitivity to durvalumab or the excipients of durvalumab or trastuzumab deruxtecan or history of severe hypersensitivity reactions to other monoclonal antibodies.\n* Major surgery within 4 weeks prior to study treatment initiation. Patients must have recovered from any effects of any major surgery.\n* Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.\n* Participant has a medical condition that requires chronic systemic steroid therapy (\\> 10 mg of prednisone daily or equivalent) or any other form of immunosuppressive medication (including disease modifying agents) and has required such therapy in the last 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[eg, colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, sarcoidosis syndrome, Wegener syndrome \\[granulomatosis with polyangiitis\\], Graves' disease, and rheumatoid arthritis, hypophysitis, uveitis, etc). The following are exceptions to this criterion:\n\n  \\-- Patients with vitiligo or alopecia, Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement, Patients with any chronic skin condition that does not require systemic therapy, Patients with celiac disease controlled by diet alone, who may also be included, but only after consultation with the Principal Investigator, Patients without active disease in the last 5 years, who may also be included but only after consultation with the Principal Investigator\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and prior pneumonectomy\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec on screening EKG\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval\n* Any of the following procedures or conditions in the 6 months prior to enrollment: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure (New York Heart Association Functional Classification Grade ≥2), and stroke. Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial infarction related symptoms, should have a cardiology consultation before enrollment to rule out myocardial infarction.\n* Cardiac ejection fraction outside institutional range of normal or \\\u003C50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition \\[MUGA\\] scan if an echocardiogram cannot be performed or is inconclusive).\n* History of another primary malignancy, except for Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, Adequately treated carcinoma in situ without evidence of disease\n* History of venous thromboembolism in the past 3 months.\n* History of active primary immunodeficiency.\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] result) or hepatitis C virus (HCV). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C antibody are eligible only if the polymerase chain reaction is negative for HCV RNA. Some medications used for these conditions have drug-drug interactions with the study treatment.\n* Known to have previously tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies)(HIV testing is not required for participation on this study)\n* Receipt of a live vaccine within 30 days prior to study treatment initiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, BCG, and typhoid vaccine. The use of the inactivated seasonal influenza vaccine is allowed.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Use of potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)\n* Use of hydroxychloroquine in \\\u003C14 days prior to Day 1 of trastuzumab deruxtecan treatment\n* History of leptomeningeal carcinomatosis\n* Female patients who are pregnant, breastfeeding or of reproductive potential who are not willing to employ effective birth control from screening to 6 months after the last dose of durvalumab and at least 7 months after the final administration of trastuzumab deruxtecan due to the potential for teratogenic effects. And unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother",{"count":331,"type":19},63,[55],"The purpose of this study is to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer.\n\nThe names of the study drugs involved in this study are:\n\n* Trastuzumab deruxtecan\n* Durvalumab",[26,335,194,336,25],"Inflammatory Breast Cancer Stage III","HER2 Low Breast Adenocarcinoma",[26,335,194,336,25],"2025-09-15",{"date":340,"type":36},"2025-09-19",{"date":342,"type":36},"2023-05-04",{"date":344,"type":19},"2032-12-01",{"name":346,"class":42},"Filipa Lynce, MD",3,{"id":349,"slug":4,"hasResults":10,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":10,"sex":51,"minAge":16,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":20,"phases":357,"briefSummary":359,"conditions":360,"keywords":361,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":72},"100587296","NCT06926543","Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy","Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)","CONCERT","Inclusion Criteria:\n\n1. Pathologically confirmed invasive breast cancer\n2. Stage IIB-III invasive breast cancer (AJCC 8th edition)\n3. Patients planned for adjuvant chemotherapy and adjuvant radiotherapy\n4. Patients fit to receive adjuvant chemotherapy and radiotherapy\n5. Age \\> 18 years\n\nExclusion Criteria:\n\n1. Hypersensitivity to taxanes\n2. Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting)\n3. Unable or unwilling for regular follow up\n4. Bilateral tumour needed RT to both sides\n5. Patients planned for RT to oligometastatic sites\n6. Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and\u002For lungs (Exceeding the protocol specific mandatory dose constraints).\n7. Pregnant patient",{"count":356,"type":19},858,[358],"PHASE3","This clinical research aims to determine if concurrent chemotherapy and radiation therapy is more effective than sequential chemotherapy and radiation therapy for patients with stage IIB-III breast cancer. It seeks to answer the following key questions:\n\n1. When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival?\n2. What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)?\n3. What are each treatment approach's financial costs?\n\nResearchers will compare the following to groups:\n\nArm A: Participants in the sequential treatment group will first undergo chemotherapy and then radiation.\n\nand Arm B: Participants in the concurrent treatment group will undergo radiation therapy while undergoing chemotherapy.\n\nParticipants are going to:\n\n1. Get the usual chemotherapy (taxanes and\u002For anthracyclines).\n2. Receive radiation therapy for three to four weeks.\n3. Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.",[26,274,273],[362,363,364,365,366],"Invasive breast cancer","Chemoradiation","Sequential","Concurrent","adjuvant therapy","2025-04-07",{"date":369,"type":36},"2025-04-13",{"date":371,"type":36},"2024-05-14",{"date":373,"type":19},"2031-05",{"name":375,"class":42},"Dr. Tabassum Wadasadawala",{"id":377,"slug":4,"hasResults":10,"nctId":378,"briefTitle":379,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":10,"sex":51,"minAge":16,"maxAge":381,"enrollmentInfo":382,"targetDuration":383,"studyType":214,"phases":4,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":386,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":4},"100537875","NCT06283511","Evaluation of the RESTART Survival Programme","Inclusion Criteria:\n\n1. Age \\>= 18 at the time of signing the ICF\n2. Minimum understanding of French\n3. Signed study informed consent form obtained prior to any study-related procedure.\n4. Participation in the RESTART programme\n5. Patient with curative breast cancer (AJCC stage I-II-III)\n\nExclusion Criteria:\n\n\\-","99 Years",{"count":236,"type":19},"15 Months","The RESTART survivorship programme has been implemented in the care pathway for patients with localised breast cancer since 2022. In this project, investigators are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme.",[26],"NOT_YET_RECRUITING","2025-02-25",{"date":389,"type":36},"2025-02-28",{"date":391,"type":19},"2025-03-01",{"date":393,"type":19},"2026-12",{"name":395,"class":42},"Jules Bordet Institute",{"id":397,"slug":4,"hasResults":10,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":10,"sex":15,"minAge":402,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":20,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":94},"100568186","NCT06677944","Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer","Impact of Preoperative Stereotactic Partial Breast Irradiation on Treatment Response, Treatment-related Toxicity, and Cosmetic Outcomes in Early-stage Breast Cancer: A Prospective, Phase II Clinical Trial","Inclusion Criteria:\n\n* Histologically confirmed ductal carcinoma in situ (DCIS) and invasive breast cancer.\n* Age ≥ 45\n* cT1\u002FcN0, tumor size ≤ 2.5cm\n* ECOG 0\\~2 -ER+, HER2-\n\nExclusion Criteria:\n\n* cN+\n* Tumor located too close to the skin or chest wall (within 5 mm)\n* With previous treatment history for breast cancer\n* Neoadjuvant chemotherapy\n* Multicentric disease\n* Diffuse microcalcification\n* BRCA mutation\n* Paget's disease\n* In cases where tumor delineation is not achievable on CT\u002FMRI images","45 Years",{"count":404,"type":19},47,[55],"In the management of early breast cancer patients, postoperative radiotherapy following breast-conserving surgery has been established as the standard treatment. Over the past two decades, significant changes have occurred in radiotherapy for breast cancer, encompassing dose fractionation methods, radiotherapy techniques, and delineation of the radiation field. Hypofractionated radiotherapy has been reported in numerous randomized phase 3 studies to show equivalent tumor control rates, reduced acute side effects, and similar late side effects compared to conventional fractionation. Among hypofractionated radiotherapy approaches, particularly in early-breast cancer, accelerated partial breast irradiation (APBI) may be chosen over whole breast irradiation (WBI). This approach is based on data indicating that the majority of local recurrences in breast cancer occur around the site of the primary tumor. By targeting radiation to the involved breast region, it becomes possible to increase the dose per fraction while shortening the overall treatment duration due to the smaller radiation treatment volume. While careful patient selection is crucial, multiple clinical studies have demonstrated that APBI, particularly after breast-conserving surgery, yields satisfactory local control rates comparable to WBI. This is accompanied by reduced side effects, improved convenience, enhanced quality of life, and potential cost savings.\n\nTraditionally, APBI has been administered after surgery, but there is a recent trend to explore preoperative APBI. The rationale for performing preoperative APBI includes several considerations. Firstly, compared to postoperative APBI, the precise location of visually identifiable tumors allows for more accurate and targeted radiation therapy, minimizing the impact on adjacent normal tissues and achieving superior cosmetic results. Secondly, reducing the size of the preoperative lesion may enable more conservative surgery, decreasing the extent of the surgical procedure. Thirdly, it can serve as a preparatory treatment to assess tumor responsiveness. Fourthly, in some cases, it may be administered for definitive purposes, especially in elderly or frail women who may find it challenging to undergo standard treatment due to concurrent health issues.\n\nSeveral clinical studies have reported the effectiveness and validity of preoperative PBI in a few cases of early breast cancer. These studies have shown low rates of acute and chronic toxicity, with excellent cosmetic outcomes. While accumulating evidence supports preoperative PBI, there is currently a lack of comparative studies with postoperative PBI. Therefore, this study aims to compare and evaluate the overall clinical advantages, including safety and efficacy, of preoperative PBI and postoperative PBI in early breast cancer patients.",[25,408,26],"Ductal Carcinoma in Situ","2024-11-06",{"date":411,"type":36},"2024-11-07",{"date":413,"type":36},"2023-10-13",{"date":415,"type":19},"2026-10-12",{"name":417,"class":42},"Yonsei University",""]