Phase 3 Study Comparing Camrelizumab, Apatinib, and Eribulin Combo Versus Doctors Choice Chemotherapy for Advanced Triple-Negative Breast Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a combination treatment using camrelizumab, apatinib, and eribulin compared to the physicians choice chemotherapy for women with advanced triple-negative breast cancer TNBC. The study focuses on whether this triple-drug regimen can improve progression-free survival and overall survival. Secondary goals include measuring response rates, disease control, clinical benefits, and quality of life, alongside analyzing biomarkers and tracking side effects. Participants in the experimental group receive camrelizumab intravenously on day 1, apatinib orally once daily, and eribulin intravenously on days 1 and 8, all in repeating 21-day cycles. The control group is treated with chemotherapy selected by their physician. This phase III randomized trial compares these two approaches as later-line treatments for advanced TNBC. During the study, participants will undergo regular assessments including imaging to measure tumor response, monitoring for adverse events, and quality of life surveys. Researchers will track progression-free survival up to 60 months and overall survival up to 120 months. Secondary outcomes such as response rate and disease control are assessed up to 12 to 18 months. Safety is monitored from treatment start until 30 days after the last dose. The total study participation could last several years, with ongoing evaluations to understand the treatment impact.

Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer