Actively Recruiting
Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）
Led by Hebei Medical University Fourth Hospital · Updated on 2025-12-11
144
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multi-center, randomized, prospective phase II clinical trial aimed at exploring and evaluating the efficacy of dalpiciclib combined with AI in neoadjuvant treatment for ER strong positive（ER≥50%），HER2-negative, Ki-67≤20%,T1-3N1M0 postmenopausal breast cancer. The primary objectives are to demonstrate non-inferiority in efficacy compared to chemotherapy and to assess its superior safety profile.
CONDITIONS
Official Title
Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Postmenopausal female with confirmed invasive breast cancer.
- Clinical stage T1-3N1M0 breast cancer.
- Strong positive estrogen receptor (≥50%) and HER2 negative confirmed by pathology.
- No prior treatment for breast cancer.
- No significant cardiac disease with baseline left ventricular ejection fraction ≥50% and NYHA class ≤ I.
- ECOG performance status of 0 or 1 and suitable for chemotherapy without major organ dysfunction.
- Normal routine blood tests within 1 week prior to enrollment: neutrophils ≥1.5x10^9/L, white blood cells ≥3.0x10^9/L, platelets ≥90x10^9/L, hemoglobin ≥90 g/L.
- Normal liver and kidney function within 1 week prior to enrollment: total bilirubin ≤1.5x upper limit of normal, ALT/AST ≤2x upper limit of normal, serum creatinine ≤1.5x upper limit of normal or creatinine clearance ≥60 ml/min.
- Negative pregnancy test for women of childbearing age; use medically acceptable contraception if premenopausal during study.
- Good compliance with study requirements.
You will not qualify if you...
- Pregnant or lactating women or women with positive pregnancy test at baseline who do not agree to use effective contraception.
- History of severe allergic reactions to investigational drugs or documented drug allergies.
- Bilateral breast cancer or inflammatory breast cancer.
- Metastatic (stage IV) breast cancer at initial diagnosis.
- History of congestive heart failure, unstable angina, arrhythmias, or myocardial infarction.
- Current acute lung conditions or interstitial lung disease.
- Severe liver diseases including acute hepatitis or coagulation factor synthesis disorders; positive HBV markers require low HBV DNA levels.
- Any serious medical conditions or comorbidities affecting safety or study participation.
- Other invasive malignancies that could interfere with study evaluation.
- Prior chemotherapy, endocrine therapy, or anti-HER2 therapy for breast cancer (except diagnostic biopsy).
- Major surgery within 4 weeks prior or unresolved significant medical conditions.
- Non-measurable tumors during treatment.
- Any condition deemed unsuitable by the investigator for study participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
Research Team
L
lina zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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