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.
Parallel
Pembrolizumab injection
DrugOn Day 1 of each cycle for a total of 9 cycles; intravenous (IV) infusion
Capecitabine tablets
Drug1250 mg/m² BID, on days 1-14 of each 21-day cycle; 8 cycles Dose reduction at 825 mg/m² BID during radiotherapy if indicated
Local radiotherapy
RadiationLocal radiotherapy will be performed as per standard practice if indicated.
2-year Invasive Disease-free survival (iDFS)
Invasive disease free survival (iDFS) defined as time from randomization to the first of the following events: local, regional or distant recurrence, or second primary cancer (including contralateral) or death due to any cause.
Overall survival (OS)
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Distant disease-free survival (DDFS)
Distant disease-free survival (DDFS) is defined as the time from the date of inclusion to the date of distant relapse or death due to any cause, whichever occurs first.
Efficacy (iDFS, OS and DDFS)
iDFS, OS and DDFS will also be compared to the external cohort of TNBC patients without pCR after NAC and treated with adjuvant pembrolizumab as part of standard of care after surgery .
Acute and late toxicity during the study
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
