Study of Pyrotinib with Trastuzumab for Women with Residual HER2-Positive Breast Cancer After Pre-Surgery Treatment

What this Trial Is About

Researchers are evaluating pyrotinib as an additional treatment for women with residual invasive HER2-positive breast cancer after they have received neoadjuvant chemotherapy combined with anti-HER2 therapies. This Phase 3, prospective, randomized, multicenter, open-label study aims to determine if pyrotinib can further reduce the risk of cancer recurrence beyond the standard one-year trastuzumab treatment with or without pertuzumab. Participants are randomly assigned to one of two groups one group receives pyrotinib 400 mg orally once daily for one year along with trastuzumab, while the other group undergoes observation follow-up without pyrotinib. The study does not use a placebo control, and treatment assignment is open to both researchers and participants. During the study, participants will be monitored for invasive disease-free survival up to two years from randomization. Researchers will also assess disease-free survival and overall survival within the same timeframe. Safety will be evaluated throughout the study, and participants will be followed for adverse events and response outcomes. The trial is sponsored by RenJi Hospital and involves women aged 18 to 70 years who meet specific health and treatment criteria.

Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer