Phase II Study of Capecitabine Added to Pembrolizumab After Surgery for Triple Negative Breast Cancer with Remaining Disease Post-Chemo-immunotherapy

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining pembrolizumab and capecitabine as a post-operative treatment for patients with triple negative breast cancer TNBC who have residual disease after receiving neoadjuvant chemotherapy with pembrolizumab. This Phase II trial aims to measure invasive disease-free survival over two years in this patient group, comparing the investigational treatment to a standard care cohort treated with pembrolizumab alone. Participants in the experimental arm will receive pembrolizumab at a fixed dose of 200 mg intravenously every three weeks for a total of nine cycles during the adjuvant phase. Capecitabine tablets will be taken orally at 1250 mgm twice daily for 14 days followed by 7 days off, repeated for eight cycles, with dose reduction during radiotherapy if needed. Local radiotherapy will be given as per standard practice when indicated. An external cohort receiving standard care pembrolizumab after surgery will be observed for comparison. During the study, participants will undergo assessments to monitor survival outcomes including invasive disease-free survival, overall survival, and distant disease-free survival for up to 3.5 years. Safety will be evaluated by tracking acute and late toxicities throughout the study period. Participants will have laboratory tests, tumor tissue analysis, and clinical examinations as part of their follow-up. The trial runs until August 2028 and includes regular visits and monitoring to evaluate treatment effects and safety.

Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery