[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,77,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100053974","phase-2-cdk46-inhibitors-combined-with-endocrine-therapy-for-neoadjuvant-treatment-100053974",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":21,"type":22},158,"ESTIMATED","INTERVENTIONAL",[25],"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",[28,29,30,31,32],"Hormone Receptor-Positive Breast Cancer","High-risk Breast Cancer","Early-Stage Breast Cancer","HER2-negative Breast Cancer","ctDNA Monitoring","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2026-04-20",{"date":41,"type":22},"2029-12-31",{"name":43,"class":44},"Peking University People's Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":76,"locationsCount":45},"100053782","phase-2-ctdna-guided-de-escalation-of-adjuvant-chemotherapy-with-dalpiciclib-in-hr-positiveher2-negative-breast-cancer-100053782","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.",{"count":55,"type":22},393,[25],"* 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.",[28,29,30,31,32,59],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[61,62,63,64,65,66,67,68,69,70,71],"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",{"date":36,"type":37},{"date":74,"type":37},"2025-08-01",{"date":41,"type":22},{"name":43,"class":44},{"id":78,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":26,"conditions":81,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":89,"locationsCount":4},"100621091",{"count":21,"type":22},[25],[28,29,30,31,32],"NOT_YET_RECRUITING","2026-01-18",{"date":85,"type":37},"2026-01-26",{"date":87,"type":22},"2026-02-01",{"date":41,"type":22},{"name":43,"class":44},{"id":91,"slug":4,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":57,"conditions":95,"keywords":96,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":101,"locationsCount":45},"100590706","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-3N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 ≥20%);\n  2. 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.",{"count":55,"type":22},[25],[28,29,30,31,32,59],[61,62,63,64,65,66,67,68,69,70,71],{"date":98,"type":37},"2026-01-21",{"date":74,"type":37},{"date":41,"type":22},{"name":43,"class":44}]