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

StatusRecruiting
PhasePhase 2
Started2023-09-30
View on ClinicalTrials.gov ↗

Amendment history

2025-12-04
Study Status v1
Primary completion date2024-12-01→2026-12-01
Completion date2025-12-01→2028-12-01
2023-10-25
Original filing
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.
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