Phase II Study of All Trans Retinoic Acid with Toripalimab Plus Chemotherapy for Treating Women with Advanced or Metastatic Triple Negative Breast Cancer

What this Trial Is About

Researchers are evaluating a combination treatment involving All Trans Retinoic Acid together with Toripalimab plus chemotherapy for women with locally advanced inoperable or metastatic triple negative breast cancer TNBC. This phase II trial aims to investigate this treatment approach across multiple centers and groups to better understand its impact on this aggressive form of breast cancer. Participants will be assigned to one of two treatment groups. Cohort 1 will receive Toripalimab intravenously every 21 days along with albumin paclitaxel on days 1 and 8, plus oral All Trans Retinoic Acid taken twice daily from day 3 to day 11 during each 21-day treatment cycle. Cohort 2 will receive Toripalimab intravenously every 21 days plus a chemotherapy regimen that may include monoclonal antibodies, elibulin, utideron, gemcitabine, albumin paclitaxel, or capecitabine, alongside oral All Trans Retinoic Acid following the same dosing schedule. Treatment courses last 21 days and may continue based on patient response and tolerability. During the study, participants will undergo biopsies or provide tumor samples for biomarker analysis, including PD-L1 expression. Researchers will monitor tumor response, overall survival, progression-free survival, duration of response, and adverse events including skin reactions for up to two years. Participants will have regular assessments to evaluate treatment effects and safety. The study began in November 2024 and is planned to continue until September 2029.

All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial