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
UNICANCER
220 participants
Mar 11, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
On Day 1 of each cycle for a total of 9 cycles; intravenous (IV) infusion
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
Local radiotherapy will be performed as per standard practice if indicated.
Locations(20)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05973864