Phase II Study of Biolosion with Standard Neoadjuvant Therapy for Treating Locally Advanced Triple-negative Breast Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a compound preparation called Biolosion, taken alongside standard neoadjuvant therapy for women with locally advanced triple-negative breast cancer. This Phase II randomized study aims to compare the combined treatment to standard therapy alone. The study is sponsored by Sun Yat-sen University and focuses on patients who have not previously received chemotherapy or targeted therapy for advanced breast cancer. Participants will be randomly assigned to one of two groups. One group will receive standard therapy consisting of chemotherapy drugs paclitaxel-carboplatin or docetaxel-carboplatin followed by doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide combined with a PD-1 antibody, along with the oral probiotic Biolosion taken nightly for 21 days after each cycle. The other group will receive the same standard therapy without Biolosion. Treatment will last for 24 weeks. During the study, participants will be closely monitored with tumor tissue testing for PD-L1 expression, imaging, and pathology evaluations. Researchers will assess the primary outcome of pathological complete remission at the end of treatment. Secondary outcomes include overall survival and disease-free survival over five years. Safety assessments and follow-up visits will support adherence and measure treatment impact throughout the study period, which extends through long-term observation.

Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer