Overview

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

Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Hebei Medical University Fourth Hospital
Treatments:
Aromatase Inhibitors
Cyclophosphamide
Docetaxel
Epirubicin