Clinical Trial

Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-10-25.
Trial Details
NCT Number NCT06107673
Lead Sponsor Hebei Medical University Fourth Hospital
Conditions Breast Cancer
Enrollment 144 participants
Start Date 2023-09-30
Primary Completion 2026-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-11