[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621091":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":19,"responsibleParty":30,"collaborators":19,"id":33,"slug":19,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":19,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":19,"overallStatus":56,"whyStopped":19,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":19},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CDK4\u002F6 inhibitor with endocrine therapy","EXPERIMENTAL","Patients receive 4 cycles of neoadjuvant CDK4\u002F6 inhibitor with endocrine therapy. Post-surgery treatment is guided by ctDNA status:\n\nctDNA-negative at baseline and post-neoadjuvant, with post-op Ki67 ≤10% ：Continue CDK4\u002F6 inhibitor with endocrine therapy for 2-3 years.\n\nctDNA-positive → negative, or persistently ctDNA-negative with post-op Ki67 \\>10% :\n\nRandomized 1:1 to:\n\nArm 1: CDK4\u002F6 inhibitor with endocrine therapy for 2-3 years. Arm 2: Adjuvant chemotherapy (investigator's choice) → CDK4\u002F6 inhibitor with endocrine therapy for 2-3 years.\n\n（3）Persistently ctDNA-positive or ctDNA-negative → positive: Adjuvant chemotherapy → CDK4\u002F6 inhibitor with endocrine therapy for 2-3 years.\n\nPremenopausal women receive ovarian suppression with LHRH agonists.",[13],"Drug: CDK4\u002F6 inhibitor with endocrine therapy",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","CDK4\u002F6 inhibitor with endocrine therapy for neoadjuvent therapy",[9],null,[21],{"name":22,"affiliation":5,"role":23},"shu wang, doctor","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"yuan peng, doctor","CONTACT","86+13671287670","13671287670@163.com",{"type":23,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Shu Wang","director of breast center","100621091",false,"NCT07366112","CDK4\u002F6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment","CDK4\u002F6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment of Breast Cancer: ctDNA-Guided Personalized Therapy","DNACDKHR","Inclusion Criteria:\n\n* 1.Female breast cancer patients aged ≥18 years and ≤75 years, either postmenopausal or premenopausal\u002Fperimenopausal; 2.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); 3. At least one evaluable lesion per RECIST 1.1, with clinical staging meeting:\n\n  \u003C!-- -->\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; 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 5.Willing to participate in the study and voluntarily sign informed consent; 6.Agree to undergo ctDNA testing during treatment; 7.Adequate organ and bone marrow function defined as:\n\n  \u003C!-- -->\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; 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* 1.Bilateral breast cancer; 2.Prior history of breast cancer (including ductal carcinoma in situ or invasive breast cancer); 3.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); 4.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; 5.History of severe pulmonary diseases (e.g., interstitial pneumonia); 6. 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; 7.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; 8.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; 9.Known allergy to any component of the study drugs; 10.Current participation in another interventional drug clinical study; 11.Pregnancy or lactation; 12.Refusal to comply with follow-up; 13.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":44,"type":45},158,"ESTIMATED","INTERVENTIONAL",[48],"PHASE2","Exploring the dynamics of ctDNA following neoadjuvant therapy with CDK4\u002F6 inhibitors combined with endocrine treatment, and its potential to guide de-escalation of adjuvant chemotherapy",[51,52,53,54,55],"Hormone Receptor-Positive Breast Cancer","High-risk Breast Cancer","Early-Stage Breast Cancer","HER2-negative Breast Cancer","ctDNA Monitoring","NOT_YET_RECRUITING","2026-01-18",{"date":59,"type":60},"2026-01-26","ACTUAL",{"date":62,"type":45},"2026-02-01",{"date":64,"type":45},"2029-12-31",{"name":5,"class":6}]