NCT05973864

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

A Phase II Study to Evaluate CAPecitabine Plus Pembrolizumab as Post-operative Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Chemo-immunotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

We propose to evaluate the benefit in 2-year iDFS and safety of adding capecitabine to pembrolizumab in post-operative phase of pembrolizumab-containing treatment, in the subgroup of localized TNBC patients with residual disease. An external cohort with patients treated with pembrolizumab as part of standard care after surgery, for localized TNBC without pCR after NAC, and with similar eligibility criteria, will be registered in an ambispective way, allowing comparisons between the experimental arm and this external cohort. All the centers involved in the study will participate in the registration of the needed information concerning this cohort.

Conditions

• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Pembrolizumab injection	On Day 1 of each cycle for a total of 9 cycles; intravenous (IV) infusion
DRUG	Capecitabine tablets	1250 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
RADIATION	Local radiotherapy	Local radiotherapy will be performed as per standard practice if indicated.

Timeline

• Start date: 2025-03-11
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2023-08-03
• Last updated: 2025-11-17

Locations

20 sites across 1 country: France