Clinical Trial

A Phase II Study to Evaluate the Efficacy and Safety of Anti-HER2 Triple-targeted Drugs Combined With CDK4/6 Inhibitors in Neoadjuvant Therapy for ER-positive HER2-positive Breast Cancer Patients.

Study acronym: Cinderella-Neo
Not Yet Recruiting Phase 2
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Summary
To further enhance treatment efficacy, minimize reliance on chemotherapy, and identify the optimal neoadjuvant approach for ER-positive and HER2-positive population, we have designed a single-arm, phase II clinical trial. This study aims to evaluate the efficacy and safety of a novel regimen integrating CDK4/6 inhibitors intensified endocrine therapy and dual HER2-targeted monoclonal antibodies plus the tyrosine kinase inhibitor pyrotinib.
Trial Details
NCT Number NCT07290166
Lead Sponsor Fudan University
Conditions Breast Cancer
Enrollment 42 participants
Start Date 2025-12-31
Primary Completion 2027-10-31 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-18