Study of Toripalimab Plus Chemotherapy for Advanced HER2-Negative Breast Cancer Including Triple-Negative and Hormone-Receptor-Positive Types

What this Trial Is About

Researchers are evaluating the effectiveness and safety of toripalimab combined with chemotherapy chosen by the doctor in patients with advanced HER2-negative breast cancer who have not responded to previous treatments. The study is a phase 2 trial that includes different groups based on breast cancer types and prior treatment history, focusing on patients with triple-negative breast cancer and hormone receptor-positive disease. Participants receive toripalimab along with chemotherapy selected by their doctor. The study involves three groups one with triple-negative breast cancer previously treated with immune-checkpoint inhibitors, one with triple-negative breast cancer without prior immune therapy, and one with hormone receptor-positive, HER2-negative breast cancer. Treatment is given during the main study period starting in January 2026. During the study, researchers will monitor tumor response every 8 weeks for the first 24 weeks and then every 12 weeks. They will also assess progression-free survival, disease control, duration of response, overall survival, and safety over up to 3 years. Participants will have regular visits for evaluations, including scans and lab tests. Safety will be tracked from consent until 30 days after the last treatment dose, with ongoing follow-up to understand the treatments effects.

A Multicohort Study of Toripalimab in Combination With Investigator-Selected Chemotherapy for Advanced HER2-Negative Breast Cancer