Cadonilimab With Chemotherapy for Treating Recurrent or Metastatic Triple Negative Breast Cancer Phase 2 Study Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Cadonilimab combined with chemotherapy as a first or second-line treatment for patients with recurrent or metastatic triple-negative breast cancer TNBC. TNBC has poor prognosis and limited treatment options. This phase II, open-label, non-randomized study aims to enroll 27 patients to better understand how this combination therapy works compared to chemotherapy alone, addressing limitations caused by toxicities in previous antibody combinations targeting CTLA-4 and PD-1 pathways. Participants will receive Cadonilimab at a dose of 10 mgkg intravenously every three weeks along with chemotherapy, where the specific chemotherapy regimen is chosen by the treating physician. The study follows a Simon two-stage design and is conducted across multiple centers. This treatment period marks the first or second-line therapy for recurrent or metastatic TNBC, depending on prior chemotherapy timing. During the study, researchers will monitor patients for treatment response using objective response rate measures for up to two years. Safety assessments include tracking adverse events from consent signing through 90 days after the last dose. Participants will undergo evaluations of measurable lesions, performance status, and organ function. The total participation duration includes treatment and follow-up to assess both efficacy and safety outcomes.

Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer