RecruitingPhase 2NCT05973864

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


Sponsor

UNICANCER

Enrollment

220 participants

Start Date

Mar 11, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding pembrolizumab (an immunotherapy drug) to capecitabine (a chemotherapy pill) helps prevent triple-negative breast cancer from coming back after patients have already completed chemotherapy plus immunotherapy and surgery. **You may be eligible if...** - You are 18 or older - You have triple-negative breast cancer (a type that lacks hormone and HER2 receptors) - You previously received at least 6 cycles of standard chemotherapy before surgery - You still had cancer remaining in the breast or lymph nodes after surgery (residual disease) - You have recovered well enough from surgery **You may NOT be eligible if...** - You have already received pembrolizumab or other PD-1/PD-L1 immunotherapy drugs - You have had a prior different type of breast cancer treated with similar drugs - You have active autoimmune disease - You have serious heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab injection

On Day 1 of each cycle for a total of 9 cycles; intravenous (IV) infusion

DRUGCapecitabine 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

RADIATIONLocal radiotherapy

Local radiotherapy will be performed as per standard practice if indicated.


Locations(20)

CHU Amiens Picardie_Site Sud

Amiens, France

Institut Sainte Catherine

Avignon, France

Centre Hospitalier de la Côte Basque

Bayonne, France

CHU Jean Minoz

Besançon, France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

Centre François Baclesse

Caen, France

Centre Georges-François Leclerc

Dijon, France

CHD Vendee

La Roche-sur-Yon, France

Centre Oscar Lambret

Lille, France

Centre Léon Bérard

Lyon, France

Institut Paoli-Calmettes

Marseille, France

Institut Curie

Paris, France

Clinique de La Croix du sud

Quint-Fonsegrives, France

Institut Godinot

Reims, France

Institut Curie

Saint-Cloud, France

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, France

Centre Paul Strauss

Strasbourg, France

Institut Claudius Regaud, IUCT Oncopole

Toulouse, France

CHU Bretonneau

Tours, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

View Full Details on ClinicalTrials.gov

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NCT05973864


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