Phase 3 Study Comparing TQB2930 Plus Chemotherapy to Trastuzumab Plus Chemotherapy in Adults With HER2-Positive Advanced Breast Cancer Who Have Had Prior Anti-HER2 Treatments

What this Trial Is About

Researchers are investigating treatments for HER2-positive advanced breast cancer in patients who have already received at least two prior anti-HER2 therapies. This Phase III clinical trial compares the effects and safety of TQB2930, a HER2 bispecific antibody drug, combined with chemotherapy, against trastuzumab combined with chemotherapy. The study aims to evaluate which treatment approach may better manage advanced breast cancer that has progressed despite prior therapies. Participants are randomly assigned to one of two groups. One group receives TQB2930 injection at 30 mgkg every three weeks along with a chemotherapy agent chosen by the investigator, with each treatment cycle lasting 21 days. The other group receives trastuzumab starting with an 8 mgkg dose followed by 6 mgkg every three weeks, combined with investigator-selected chemotherapy, also given in 21-day cycles. Chemotherapy options include drugs like Capecitabine, Gemcitabine, Vinorelbine, or Eribulin. Throughout the study, participants undergo regular assessments to monitor disease progression and treatment response, including scans and evaluations lasting about one to two years. The main outcome measured is progression-free survival as assessed by an independent review committee. Additional outcomes include overall survival, duration of response, tumor response rates, and safety monitoring for adverse events. Blood samples are collected at specific cycles to measure drug levels and immune responses. The study includes safety follow-up for 90 days after the last dose or until another anticancer treatment begins.

TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer