Study on Switching Between HP plus Chemotherapy and HPy plus Chemotherapy in Women with HER-2 Positive Advanced or Metastatic Breast Cancer

What this Trial Is About

Researchers are investigating the effects of switching between two targeted treatment strategies, HP plus chemotherapy and HPy plus chemotherapy, in female patients with HER-2 positive advanced or metastatic breast cancer. This observational study includes approximately 600 patients from about 20 research centers nationwide. Separate analyses will be conducted for patients with de novo stage IV disease, recurrent metastatic breast cancer who have not received trastuzumab, and those with brain metastases, but these groups will not be part of the overall analysis. Participants will be naturally assigned in equal numbers to either switch from HP plus chemotherapy to HPy plus chemotherapy or vice versa. If the first-line treatment fails, patients will switch to the alternative regimen during second-line treatment. Treatment continues until disease progression, intolerable side effects, or other reasons for stopping. Chemotherapy cycles are recorded, and if patients cannot tolerate taxanes, alternative drugs like vinorelbine, capecitabine, or eribulin may be used. After chemotherapy or stopping treatment, maintenance therapy may be given based on clinical need. During the study, patients will be monitored every two cycles for disease status, lab tests, drug use, medications, and side effects. After treatment ends, survival follow-up will occur every three months for up to three years to track patient survival. The main outcome measured is progression-free survival assessed by investigators over 60 months, with overall survival also tracked during this time.

A Study on the Efficacy and Safety of Switching Between Two Targeted Strategies, HP+Chemotherapy and HPy+Chemotherapy, After Treatment Progression in HER-2 Positive Advanced or Metastatic Breast Cancer