Actively Recruiting
ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Early-Stage Breast Cancer
Led by Peking University People's Hospital · Updated on 2026-01-21
393
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach for women with hormone receptor-positive, HER2-negative early-stage breast cancer who are at high risk of recurrence. This Phase II randomized clinical trial studies whether using circulating tumor DNA (ctDNA) to guide treatment can safely reduce the need for chemotherapy, by combining the CDK4/6 inhibitor Dalpiciclib with endocrine therapy. The aim is to find out if this personalized strategy maintains clinical benefits while decreasing chemotherapy side effects. Participants are divided into two groups: one receives standard taxane-based chemotherapy before surgery, followed by optional additional therapy based on doctor recommendation. The other group receives Dalpiciclib plus aromatase inhibitors for four cycles before surgery. After surgery, treatment in the second group is adjusted according to ctDNA test results; those without detectable ctDNA continue Dalpiciclib and endocrine therapy for two years, while those with detectable ctDNA may receive chemotherapy followed by targeted therapy. Premenopausal women in this group also receive ovarian suppression. During the study, participants undergo ctDNA testing at baseline and before surgery to monitor treatment response. Imaging scans like MRI or CT are done every two cycles during pre-surgery therapy, along with pathological examination after surgery. Safety is closely monitored through lab tests, ECGs, and recording side effects. Follow-up visits continue every 3 months after treatment to track cancer recurrence and survival over a 3-year period. The main outcomes measured are ctDNA clearance after neoadjuvant therapy and event-free survival at three years.
CONDITIONS
Brief 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 breast cancer patients aged 18 to 75 years, including premenopausal, perimenopausal, or postmenopausal women
- Pathologically confirmed hormone receptor-positive (ER/PR ≥10%) and HER2-negative invasive breast cancer
- Clinical stage T1c-T3N0M0 with high-risk features (grade 3 or grade 2 with Ki67 ≥20%) or any tumor with lymph node involvement (TN+M0)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Willingness to participate and sign informed consent
- Agree to undergo ctDNA testing during treatment
- Adequate organ and bone marrow function including specific blood counts, liver and kidney function, and cardiac function within defined limits
- Negative pregnancy test within 7 days before 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 by current pathology
- Inflammatory breast cancer
- Stage IV (metastatic) breast cancer
- Bilateral breast cancer
- Prior history of breast cancer or ductal carcinoma in situ
- Any prior antitumor therapy for current breast cancer including systemic or local treatments
- Diagnosis of any malignancy within 5 years except certain cured skin or cervical cancers
- Severe pulmonary diseases such as interstitial pneumonia
- HIV/AIDS, active hepatitis B or C infection, or co-infection
- Recent serious cardiovascular events within 6 months before randomization
- Severe active infection within 4 weeks before randomization or unexplained fever >38.5°C
- Known allergy to study drugs
- Current participation in another interventional drug trial
- Pregnancy or breastfeeding
- Refusal to comply with follow-up
- Other severe physical or mental illnesses or lab abnormalities increasing study risk or interfering with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 16 weeks
Participants receive 4 cycles of neoadjuvant therapy: either dalpiciclib combined with aromatase inhibitors or taxane-based chemotherapy before surgery.
Visits every 4 weeks during neoadjuvant therapy (approximately 4 visits)
Duration - Surgery day and immediate post-operative period
Participants undergo surgery to remove the tumor after completing neoadjuvant therapy.
1 surgical visit (in-person)
Duration - Up to 2 years
Post-surgery treatment is guided by ctDNA status. Participants may continue dalpiciclib plus endocrine therapy for up to 2 years, receive adjuvant chemotherapy followed by dalpiciclib plus endocrine therapy, or receive chemotherapy followed by dalpiciclib plus endocrine therapy depending on their ctDNA results and other factors.
Clinic visits every 12 weeks during adjuvant therapy
Duration - Up to 3 years post-surgery
Participants are monitored for event-free survival and safety with regular assessments for recurrence and survival after completing treatment.
Clinic visits every 3 months for up to 3 years
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here