Treatment Study of Toripalimab Combined With Chemotherapy for Triple Negative Breast Cancer A Phase 2 Single-Group Multi-Center Trial

What this Trial Is About

Researchers are evaluating the use of Toripalimab combined with neoadjuvant chemotherapy as an adjuvant treatment for triple-negative breast cancer TNBC. This phase II, prospective, single-arm, multi-center clinical trial aims to assess the pathologic complete response PCR rate along with the types and frequency of side effects. Secondary objectives include monitoring disease-free survival, progression-free survival, and objective response rate in participants. The treatment involves two phases of neoadjuvant chemotherapy combined with Toripalimab administered intravenously every three weeks. The first phase includes Epirubicin, Cyclophosphamide, and Toripalimab for six weeks, followed by Albumin-bound Paclitaxel plus Toripalimab for another six weeks. After four treatment cycles, participants undergo radical breast cancer surgery. Postoperative therapy depends on pathology results if PCR is achieved, immunotherapy with Toripalimab continues every three weeks for one year if not, chemotherapy combined with Toripalimab continues. Gene testing on biopsy tissue and blood samples for ctDNA testing are also performed before and after treatment. During the study, participants will have regular assessments including pathology evaluation and monitoring of side effects. Researchers will track treatment response and survival outcomes over two to three years. The total involvement includes neoadjuvant treatment, surgery, postoperative therapy, and follow-up to evaluate treatment effectiveness and safety. Careful monitoring ensures adherence and collection of important biological samples for ongoing analysis.

Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02)