What this Trial Is About

This research investigates the use of pyrotinib combined with trastuzumab as maintenance therapy after first-line treatment with taxoid chemotherapy plus trastuzumab with or without pertuzumab in women with HER2-positive advanced breast cancer. The study focuses on patients whose cancer has reached stable disease, complete response, or partial response after at least four cycles of initial therapy. The main goal is to evaluate how this combined maintenance therapy affects the delay or reduction in the progression of brain metastases over an average of two years. After the initial treatment phase, participants receive capecitabine combined with pyrotinib and trastuzumab, typically for four to six cycles. This single-arm, multicenter observational study also includes patients with hormone receptor-positive cancer who receive endocrine therapy alongside pyrotinib and trastuzumab. If non-central nervous system recurrence or progression occurs, treatment may change based on the investigator's decision. The study aims to assess the incidence of brain metastases as the primary outcome. Participants will be monitored through imaging tests to confirm cancer status and recurrence, along with routine blood and organ function tests to ensure safety. The researchers will evaluate treatment effects, including brain metastases incidence and overall patient condition, over an expected survival period of at least six months. The study includes females aged 18 to 70 years who meet specific health and cancer criteria and who provide informed consent to participate.

Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC