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

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 ID
NCT06107673
Phase
PHASE2
Sponsor
Hebei Medical University Fourth Hospital
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Dalpiciclib
  • Aromatase inhibitor
  • Docetaxel injection
  • Epirubicin Hydrochloride Injection
  • Cyclophosphamide injection
Locations (sample)
  • Shijiazhuang, Hebei, China|38.04139,114.47861

Key Eligibility Criteria

  • Sign the informed consent form to participate in the clinical research.
  • Confirmed postmenopausal females diagnosed with invasive breast cancer.
  • Clinical stage T1-3N1M0.
  • Pathological examination confirmed: Strong positive for ER, negative for HER2. HER2 negative: Immunohistochemistry (IHC) suggests HER2 (-, +) or (+…

For full eligibility, visit ClinicalTrials.gov.

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