[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053782":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":40,"locations":47,"responsibleParty":63,"collaborators":45,"id":66,"slug":45,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":45,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":90,"overallStatus":49,"whyStopped":45,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Taxane Neoadjuvant Chemo ± Adjuvant Therapy","ACTIVE_COMPARATOR","Arm Description:\n\nThis group receives neoadjuvant taxane-based chemotherapy (e.g., paclitaxel 80 mg\u002Fm² weekly or docetaxel 75-100 mg\u002Fm² triweekly for 4 cycles) before surgery. Post-surgery adjuvant chemotherapy (whether or not and how to adopt depend on the physician's choice) may be administered ± CDK4\u002F6 inhibitors. The intervention aims to compare standard chemotherapy efficacy as a control.\n\nIntervention phases:\n\n* Neoadjuvant: Chemotherapy only\n* Adjuvant: Optional chemotherapy based on physician discretion ± （CDK4\u002F6 inhibitors+endocrine therapy） Key endpoints: Pathological response 0\u002F1 (RCB 0\u002F1), safety profiles.",[13],"Drug: Taxane-Based Neoadjuvant Chemotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Dalpiciclib + AI with ctDNA-Driven Adjuvant","EXPERIMENTAL","Arm Description:\n\nPatients receive 4 cycles of neoadjuvant dalpiciclib (125 mg\u002Fday, 21 days on\u002F7-off) combined with aromatase inhibitors (letrozole\u002Fanastrozole\u002Fexemestane). Post-surgery treatment is guided by ctDNA status:\n\n1. ctDNA-negative at baseline and post-neoadjuvant, with post-op Ki67 ≤10% ：Continue dalpiciclib + endocrine therapy (ET) for 2 years.\n2. ctDNA-positive → negative, or persistently ctDNA-negative with post-op Ki67 \\>10% :\n\n   Randomized 1:1 to:\n   * Arm B1: Dalpiciclib + ET for 2 years.\n   * Arm B2: Adjuvant chemotherapy (investigator's choice) → dalpiciclib + ET for 2 years.\n3. Persistently ctDNA-positive or ctDNA-negative → positive:\n\nAdjuvant chemotherapy → dalpiciclib + ET for 2 years.\n\nPremenopausal women receive ovarian suppression with LHRH agonists.",[19],"Drug: Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy","Patients receive 4 cycles of neoadjuvant dalpiciclib (125 mg orally, days 1-21 of 28-day cycles) combined with an aromatase inhibitor (letrozole\u002Fanastrozole\u002Fexemestane). Post-surgery treatment is guided by ctDNA status: （1）ctDNA-negative at baseline and post-neoadjuvant, with post-op Ki67 ≤10% :Continue dalpiciclib + endocrine therapy (ET) for 2 years； （2）ctDNA-positive → negative, or persistently ctDNA-negative with post-op Ki67 \\>10% :Randomized 1:1 to:\n\n* Arm B1: Dalpiciclib + ET for 2 years.\n* Arm B2: Adjuvant chemotherapy (investigator's choice) → dalpiciclib + ET for 2 years；（3）Persistently ctDNA-positive or ctDNA-negative → positive:\n\nMandatory adjuvant chemotherapy → dalpiciclib + ET for 2 years. Premenopausal women undergo ovarian suppression with LHRH agonists.",[15],[27,28],"Dalpiciclib\u002FAI combination therapy","SHR6390 + aromatase inhibitor",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Taxane-Based Neoadjuvant Chemotherapy","Patients receive 4 cycles of taxane-based neoadjuvant chemotherapy (e.g., paclitaxel 80 mg\u002Fm² weekly or docetaxel 75-100 mg\u002Fm² triweekly) before surgery. Post-surgery adjuvant chemotherapy (physician's choice) may be administered. This arm serves as the control group for comparing standard chemotherapy efficacy.",[9],[34,35],"Paclitaxel\u002Fcyclophosphamide neoadjuvant therapy","Docetaxel-based chemotherapy regimen",[37],{"name":38,"affiliation":5,"role":39},"shu wang, doctor","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"yuan peng, doctor","CONTACT","86+13671287670",null,"13671287670@163.com",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":56,"coordinates":57},"Point",[58,59],116.39723,39.9075,{"lat":59,"lon":58},[62],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},{"type":39,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Shu Wang","director of breast center","100053782",false,"NCT06970912","ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive\u002FHER2-Negative Breast Cancer","A Prospective, Multicenter, Randomized, Open-Label Phase II Study of ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive\u002FHER2-Negative Breast Cancer","DNADalHR","Inclusion Criteria:\n\n* Female breast cancer patients aged ≥18 years and ≤75 years, either postmenopausal or premenopausal\u002Fperimenopausal;\n* Pathologically confirmed hormone receptor-positive (HR+), HER2-negative invasive breast cancer:\n\n  1. ER-positive and\u002For PR-positive defined as: ≥10% of tumor cells showing positive staining;\n  2. HER2-negative defined as: standard immunohistochemistry (IHC) result of 0\u002F1+; or IHC 2+ with negative in situ hybridization (ISH) (confirmed by the central pathology laboratory);\n* At least one evaluable lesion per RECIST 1.1, with clinical staging meeting:\n\n  1. T1c-2N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 ≥20%);\n  2. T3N0M0;\n  3. Any TN+M0;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* Willing to participate in the study and voluntarily sign informed consent;\n* Agree to undergo ctDNA testing during treatment;\n* Adequate organ and bone marrow function defined as:\n\n  1. Absolute neutrophil count (ANC) ≥1,500\u002Fmm³ (1.5 × 10⁹\u002FL) (without granulocyte colony-stimulating factor \\[G-CSF\\] treatment within 14 days);\n  2. Platelet count (PLT) ≥100,000\u002Fmm³ (100 × 10⁹\u002FL) (without corrective therapy within 7 days);\n  3. Hemoglobin (Hb) ≥9 g\u002FdL (90 g\u002FL) (without corrective therapy within 7 days);\n  4. Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin (without corrective therapy within 7 days);\n  5. Total bilirubin (TBIL) ≤1.5×ULN (without corrective therapy within 7 days);\n  6. Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤1.5×ULN (without corrective therapy within 7 days);\n  7. Cardiac function: left ventricular ejection fraction (LVEF) ≥55%; QTc interval corrected by Fridericia's formula (QTcF) \\\u003C470 msec on 12-lead ECG;\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and agree to use non-hormonal contraception from informed consent signing until 2 months after the last treatment.\n\nExclusion Criteria:\n\n* HER2-positive breast cancer confirmed by current pathological diagnosis;\n* Inflammatory breast cancer;\n* Stage IV (metastatic) breast cancer;\n* Bilateral breast cancer;\n* Prior history of breast cancer (including ductal carcinoma in situ or invasive breast cancer);\n* Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy);\n* Diagnosis of any malignancy within 5 years prior to randomization, except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin;\n* History of severe pulmonary diseases (e.g., interstitial pneumonia);\n* HIV infection, acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥500 IU\u002FmL), hepatitis C (HCV antibody-positive with HCV RNA above the lower limit of detection), or co-infection with HBV and HCV;\n* Within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina, NYHA Class ≥II heart failure, ≥Grade 2 persistent arrhythmia (per NCI CTCAE v5.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or symptomatic pulmonary embolism;\n* Severe active infection within 4 weeks prior to randomization (requiring intravenous antibiotics, antifungals, or antivirals) or unexplained fever \\>38.5°C during screening\u002Fbefore first dose;\n* Known allergy to any component of the study drugs;\n* Current participation in another interventional drug clinical study;\n* Pregnancy or lactation;\n* Refusal to comply with follow-up;\n* Other severe physical\u002Fmental illnesses or laboratory abnormalities that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.","FEMALE","18 Years","75 Years",{"count":77,"type":78},393,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","* This is a Phase II, multicenter, randomized clinical trial evaluating a ctDNA-guided approach to de-escalate adjuvant chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer. The study aims to determine if combining the CDK4\u002F6 inhibitor Dalpiciclib with endocrine therapy can reduce the need for chemotherapy while maintaining clinical benefits.\n* Key Details ：\n\n  1. Participants: 393 women (aged 18-75) with early-stage HR+\u002FHER2- breast cancer at high risk of recurrence (e.g., tumor size ≥2 cm, lymph node involvement, or high-grade tumors).\n  2. Design: Patients are randomized 1:4 to two groups:\n\n     Group A (Chemotherapy) : Receives 4 cycles of taxane-based chemotherapy before surgery.\n\n     Group B (Experimental) : Receives Dalpiciclib + aromatase inhibitor (AI) for 4 cycles pre-surgery.\n\n     Post-surgery, treatment is adjusted based on ctDNA results.\n  3. Primary Goals ： Assess ctDNA clearance rate (conversion from detectable to undetectable ctDNA) after neoadjuvant therapy in Group B.\n\n     Evaluate 3-year event-free survival (EFS) in Group B (e.g., freedom from cancer recurrence, progression, or death).\n\n     Secondary Goals ： Safety of Dalpiciclib + endocrine therapy. Tumor response rates (e.g., complete cell cycle arrest, pathological remission).\n\n     Correlation between ctDNA clearance and long-term outcomes.\n* Why This Matters ： Current guidelines recommend chemotherapy for high-risk HR+ breast cancer, but it often causes significant side effects. This study explores a personalized approach using ctDNA-a blood-based biomarker-to identify patients who may safely avoid chemotherapy without compromising survival. If successful, it could shift clinical practice toward less toxic, targeted therapies for eligible patients.",[84,85,86,87,88,89],"Hormone Receptor-Positive Breast Cancer","High-risk Breast Cancer","Early-Stage Breast Cancer","HER2-negative Breast Cancer","ctDNA Monitoring","Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[91,92,93,94,95,96,97,98,99,100,101],"HR-positive HER2-negative breast cancer","Early-stage breast cancer","Dalpiciclib","CDK4\u002F6 inhibitor","ctDNA-guided therapy","Adjuvant chemotherapy de-escalation","Circulating tumor DNA (ctDNA)","Event-free survival (EFS)","Chemotherapy sparing","Personalized therapy","Biomarker-guided therapy","2026-07-10",{"date":104,"type":105},"2026-07-13","ACTUAL",{"date":107,"type":105},"2025-08-01",{"date":109,"type":78},"2029-12-31",{"name":5,"class":6},1]