Study Comparing Continuing Original Targeted Therapy Versus Trastuzumab with Pyrotinib and Capecitabine After Surgery in Women With HER2 Positive Early Breast Cancer Who Did Not Fully Respond to Pre-Surgery Treatment

What this Trial Is About

Researchers are evaluating the effectiveness of continuing original targeted therapy compared with a combination of trastuzumab, pyrotinib, and capecitabine as postoperative adjuvant treatments for women with HER2-positive early breast cancer who still have residual tumor after neoadjuvant therapy. This phase 2 randomized study focuses on patients who did not achieve a complete response after initial treatment and aims to improve outcomes in this specific group. Participants in the experimental group will receive pyrotinib orally once daily at 400 mg, capecitabine orally twice daily at 1000 mgm2 for 6 cycles, and trastuzumab with an initial loading dose followed by maintenance doses every 3 weeks for one year. The control group will continue their original neoadjuvant targeted therapy, which may include trastuzumab alone or combined with pertuzumab, with trastuzumab treatment lasting one year including both neoadjuvant and adjuvant phases. During the study, participants will be regularly monitored for invasive disease-free survival over a period of 3 years. Assessments will include clinical evaluations, laboratory tests, and imaging to track cancer progression and treatment effects. Safety and treatment adherence will be closely observed throughout the treatment and follow-up periods, which extend until the end of 2027.

Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer