OncoMatch/Clinical Trials/NCT05973864
Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery
Is NCT05973864 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Capecitabine tablets for triple negative breast neoplasms.
Treatment: Pembrolizumab · Capecitabine tablets — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negativity (ASCO/CAP criteria) (negative)
HER2 negativity (ASCO/CAP criteria)
Required: ESR1 less than 10% of cells stained by immunohistochemistry (IHC) (<10%)
less than 10% of cells stained by immunohistochemistry (IHC) for ER
Required: PR (PGR) less than 10% of cells stained by immunohistochemistry (IHC) (<10%)
less than 10% of cells stained by immunohistochemistry (IHC) for PgR
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: neoadjuvant chemotherapy (pembrolizumab, anthracycline, taxane) — neoadjuvant
TNBC patients previously treated by standard neoadjuvant chemotherapy with a minimum of 6 cycles of immunochemotherapy containing pembrolizumab, per standard of care (and pembrolizumab label) and anthracyclines and/or taxanes (with/without carboplatin). Other drugs may be acceptable following discussion with the sponsor (with the exclusion of capecitabine);
Cannot have received: capecitabine (capecitabine)
Has received capecitabine or other ICI than pembrolizumab in the NAC regimen
Cannot have received: immune checkpoint inhibitor
Exception: pembrolizumab allowed
Has received capecitabine or other ICI than pembrolizumab in the NAC regimen
Lab requirements
Blood counts
Adequate organ and bone marrow function. All screening lab tests should be performed within 28 days before inclusion
Kidney function
Adequate organ and bone marrow function. All screening lab tests should be performed within 28 days before inclusion
Liver function
Adequate organ and bone marrow function. All screening lab tests should be performed within 28 days before inclusion
Adequate organ and bone marrow function. All screening lab tests should be performed within 28 days before inclusion
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify