Pyrotinib in Combination With Neoadjuvant Chemotherapy in HR+/HER2-, HER4 High Expression Breast Cancer Patients: A Phase II Trial

• Status: Recruiting
• Trial end date: 2028-12-31

Summary

This is a Phase II, single-center, double-blind, placebo-controlled, randomized study of Pyrotinib in combination with Doxorubicin/Epirubicin and Cyclophosphamide followed by Docetaxel/nab-Paclitaxel as neoadjuvant therapy for women with hormone receptor positive HER2-negative stage II to III breast cancer. Patients randomized to the study arm/control arm will receive standard neoadjuvant chemotherapy in combination with pyrotinib/placebo, respectively. The primary endpoint of the study is the total pathological complete response (pCR) rate. Secondary endpoints include the pCR rate in breast only, objective response rate(ORR), event-free survival, overall survival, and toxicity. We will also explore potential prognostic and predictive biomarkers.

• Phase: Phase 2

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Liposomal doxorubicin; Paclitaxel