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Breast cancer
CAPPA
Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery (CAPPA).
- Open at Paris since : 06/03/2025
- Open at Saint-Cloud since : 14/03/2025
- Target : Adult
- Phase : Phase II
Trial description
Here is the translation:;---;**Evaluate the efficacy of postoperative capecitabine added to pembrolizumab on invasive disease-free survival (iDFS), as assessed by the investigator, in subjects with triple-negative breast cancer and residual disease following pembrolizumab-associated neoadjuvant chemotherapy.**;1. **Efficacy:** ;Evaluate the clinical impact of the capecitabine plus pembrolizumab combination in the target population in terms of: ;- Overall Survival (OS) ;- Distant Disease-Free Survival (DDFS) ;- The efficacy (iDFS, OS, and DDFS) of the experimental arm will be compared to that of an external cohort of patients treated with pembrolizumab as part of standard care after surgery for localized breast cancer without pCR following NAC. ;2. **Safety:** ;Assess the safety profile of the proposed combinations (capecitabine + pembrolizumab with or without radiotherapy in the target population).
Url of the trialMain investigator
