Study Comparing Continuous Versus Intermittent Use of Pyrotinib in Treating Invasive HER2-Positive Breast Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of continuous versus intermittent use of adjuvant pyrotinib in people with invasive HER2-positive breast cancer. This prospective, randomized, controlled, multicenter Phase 3 clinical trial aims to compare these two treatment schedules to determine which best supports patients after initial therapy. The study is sponsored by RenJi Hospital and focuses on invasive disease-free survival as the main outcome. Participants are randomly assigned to one of two groups one receives pyrotinib 400 mg orally once daily for one year, while the other takes pyrotinib 400 mg with a schedule of 14 days on treatment followed by 7 days off, repeated every 21 days for 17 cycles. The study monitors these treatment plans to assess their impact on disease control and safety over this period. Throughout the trial, participants will be closely followed for up to two years from the time of randomization to track invasive disease-free survival, overall survival, and any adverse events. Safety assessments occur from the start of pyrotinib treatment until its completion, which is approximately one year. The study also evaluates disease-free survival and overall survival during the follow-up period, ensuring comprehensive monitoring of participants health and treatment outcomes.

Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer