The goal of this clinical trial is to evaluate the efficacity and safety of pembrolizumab and capecitabine on the invasive disease-free survival, in participants who have triple negative breast cancer (TNBC) with residual disease after neoadjuvant chemotherapy associated with pembrolizumab.
Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;
Subject ≥18 years of age on day of signing informed consent form (ICF);
HER2 negativity (ASCO/CAP criteria)
AND less than 10% of cells stained by immunohistochemistry (IHC) for ER and PgR;
Radiological or clinical evidence of metastatic disease documented by imaging or clinical examination after surgery.
Has received capecitabine or other ICI than pembrolizumab in the NAC regimen;
Has a known additional malignancy, excepted skin basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer or previously treated malignancy with no evidence of disease for ≥2 years;
Any investigational anticancer therapy (chemotherapy, immunotherapy, biologic for cancer treatment) other than pembrolizumab only as adjuvant treatment.