Actively Recruiting
ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
Led by Peking University People's Hospital · Updated on 2026-01-21
393
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
* 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 CDK4/6 inhibitor Dalpiciclib with endocrine therapy can reduce the need for chemotherapy while maintaining clinical benefits. * Key Details ： 1. Participants: 393 women (aged 18-75) with early-stage HR+/HER2- breast cancer at high risk of recurrence (e.g., tumor size ≥2 cm, lymph node involvement, or high-grade tumors). 2. Design: Patients are randomized 1:4 to two groups: Group A (Chemotherapy) : Receives 4 cycles of taxane-based chemotherapy before surgery. Group B (Experimental) : Receives Dalpiciclib + aromatase inhibitor (AI) for 4 cycles pre-surgery. Post-surgery, treatment is adjusted based on ctDNA results. 3. Primary Goals ： Assess ctDNA clearance rate (conversion from detectable to undetectable ctDNA) after neoadjuvant therapy in Group B. Evaluate 3-year event-free survival (EFS) in Group B (e.g., freedom from cancer recurrence, progression, or death). Secondary Goals ： Safety of Dalpiciclib + endocrine therapy. Tumor response rates (e.g., complete cell cycle arrest, pathological remission). Correlation between ctDNA clearance and long-term outcomes. * 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.
CONDITIONS
Official Title
ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years, premenopausal, perimenopausal, or postmenopausal
- Pathologically confirmed hormone receptor-positive (ER/PR 710%) and HER2-negative breast cancer
- At least one measurable lesion according to RECIST 1.1
- Clinical stage T1c-T3N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 720%), or any node-positive (TN+M0) disease
- ECOG performance status score of 0-1
- Willingness to participate and provide informed consent
- Agreement to undergo ctDNA testing during treatment
- Adequate organ and bone marrow function: ANC 71,500/mm9, platelet count 7100,000/mm9, hemoglobin 79 g/dL, creatinine 71.5x ULN or creatinine clearance 760 mL/min, total bilirubin 71.5x ULN, AST and ALT 71.5x ULN, cardiac function with LVEF 755% and QTcF C470 msec on ECG
- Negative pregnancy test within 7 days prior to randomization for women of childbearing potential and agreement to use non-hormonal contraception until 2 months after last treatment
You will not qualify if you...
- HER2-positive breast cancer
- Inflammatory breast cancer
- Stage IV (metastatic) breast cancer
- Bilateral breast cancer
- Prior history of breast cancer, including ductal carcinoma in situ or invasive cancer
- Any prior antitumor therapy for current breast cancer
- Diagnosis of any malignancy within 5 years except certain skin cancers and cured cervical carcinoma in situ
- Severe pulmonary diseases such as interstitial pneumonia
- HIV/AIDS or active hepatitis B or C infection
- Recent serious cardiovascular events or conditions within 6 months
- Severe active infection within 4 weeks before randomization
- Known allergy to study drugs
- Current participation in another interventional drug trial
- Pregnancy or lactation
- Refusal to comply with follow-up
- Other severe physical or mental illnesses or lab abnormalities increasing study risk or interfering with results
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
yuan peng, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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