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Studies

Interventional Recruiting Phase 2

NCT05973864 on ClinicalTrials.gov

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

Official title: 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 (Estimated)
  • Study start: 2025-03-11 (Actual)
  • Primary completion: 2028-08-01 (Estimated)
  • Study completion: 2028-08-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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

Intervention / Treatment

  • Drug: Pembrolizumab injection
  • Drug: Capecitabine tablets
  • Radiation: Local radiotherapy

Primary Outcome Measures

  • 2-year Invasive Disease-free survival (iDFS) (2 years)
    Invasive disease free survival (iDFS) defined as time from randomization to the first of the following events: local, regional or distant recurrence, or second primary cancer (including contralateral) or death due to any cause.

Countries

France

Locations and Investigators

  • Centre Leon Berard, Lyon, France
    • Olivier, TREDAN
  • Hospi Grand Ouest, St Nazaire, France
    • Tifenn, L'HARIDON
  • Centre Hospitalier Departemental Vendee, La Roche Sur Yon Cedex 9, France
    • Camille, GOISLARD DE MONSABERT
  • Institut De Cancerologie Strasbourg Europe, Strasbourg, France
    • Thierry, PETIT
  • Institut Paoli-Calmettes, Marseille, France
    • Alexandre, TASSIN DE NONNEVILLE
  • Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 9, France
    • Emmanuelle, JACQUET
  • Sainte Catherine Institut Du Cancer Avignon-Provence, Avignon Cedex 9, France
    • Julien, GRENIER
  • Institut Universitaire Du Cancer Toulouse-Oncopole, Toulouse Cedex 9, France
    • Florence, DALENC
  • Centre Francois Baclesse, Caen Cedex 5, France
    • George, EMILE
  • Centr Georges Francois Leclerc, Dijon, France
    • Sylvain, LADOIRE
  • Hopital Universitaire Pitie Salpetriere, Paris Cedex 13, France
    • Johanna, WASSERMANN
  • Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France
    • Nadine, DOHOLLOU
  • Institut Godinot, Reims, France
    • Christelle, JOUANNAUD
  • Institut Curie, Saint-Cloud, France
    • Delphine, LOIRAT
  • Besancon University Hospital Center, Besancon Cedex, France
    • Laura, MANSI
  • Centre Oscar Lambret, Lille, France
  • Centre Hospitalier Regional Et Universitaire De Brest, Brest Cedex 2, France
    • Laura, DEIANA
  • Capio La Croix Du Sud, Quint-Fonsegrives, France
    • Francesco, RICCI
  • Institut De Cancerologie De Lorraine, Vandouvre-Les-Nancy, France
    • Anne, KIEFFER
  • Centre Hospitalier Universitaire Amiens Picardie, Amiens Cedex 1, France
    • Aurélie, MOREIRA
  • Institut Curie, Paris, France
    • Delphine, LOIRAT
  • Centre Hospitalier De La Cote Basque, Bayonne, France
    • Thomas, GRELLETY
  • Centre Hospital Region Metz Thionville, Metz Cedex 03, France
    • Raffaele, LONGO
  • Centre Hospitalier Regional Universitaire De Tours, Tours, France
    • Marie-Agnès, BY
  • Centre Hospitalier Et Universitaire De Limoges, Limoges Cedex 1, France
    • Elise, DELUCHE

Study Officials