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

NCT05973864 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

  • Triple Negative Breast Neoplasms

Interventions

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.

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Delphine LOIRAT, MD PhD · Institut Curie Paris

  • Jean-Yves PIERGA, MD · Institut Curie Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-11
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05973864 on ClinicalTrials.gov