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Studies

Interventional Recruiting Phase 2

NCT06078384 on ClinicalTrials.gov

Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC

Official title: Adjuvant Pembrolizumab and Chemotherapy or Surveillance in Early Triple Negative breAst Cancer With High Stromal Tumor-infiltrating Lymphocytes (TILs) Score

  • Sponsor: Unicancer
  • Collaborators: MSD France, SOLTI Breast Cancer Research Group, Gustave Roussy, Cancer Campus, Grand Paris, Vall Hebron Insitut Recerca
  • Enrollment: 354 (Estimated)
  • Study start: 2024-12-27 (Actual)
  • Primary completion: 2032-01-01 (Estimated)
  • Study completion: 2032-01-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Cohort of patients with T 1b/c N 0 M 0 TNBC aged \> 40 years with 30% ≤ sTILs \< 50% and those aged ≤ 40 years with 30% ≤ sTILs \< 75%: Pembrolizumab will be administered at a fixed dose of 200 mg every 3 weeks (Q 3W), with a total of 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles at adjuvant phase of the treatment; Cohort of patients with T 1b/c N 0 M 0 TNBC aged \> 40 years and sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75%: No treatment will be administered. These patients will undergo standard surveillance every 6 months according to local practice.
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

Triple-negative breast cancer (TNBC) is a group of tumors that occurs mainly in young, premenopausal women and accounts for 10-20% of breast cancers. Over the past decade, the incidence of women diagnosed with early-stage TNBC has significantly increased due to the widespread use of screening mammography. Treatment of patients with localized TNBC mainly involves surgery and (neo)adjuvant chemotherapy with or without radiotherapy. However, the benefit of chemotherapy may be controversial in patients with early-stage TNBC defined by small size and absence of lymph node involvement, and with significant tumor lymphocyte infiltration.

The ETNA study is a phase II trial designed to evaluate a chemotherapy de-escalation strategy in patients with TNBC T1b/c N0M0 and stromal TILs (sTILs) ≥ 30%. ETNA comprises two cohorts defined according to the level of TILs and the age of patients. Patients aged \> 40 years with 30% ≤ sTILs \< 50% and those aged ≤ 40 years with 30% ≤ sTILs \< 75% will be included in the cohort 1 and will receive adjuvant pembrolizumab 200 mg every three weeks for 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles. Patients aged \> 40 years with sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75% will be included in cohort 2 and will not receive adjuvant treatment, they will undergo standard surveillance every six months.

Conditions

  • Triple-negative Breast Cancer

Intervention / Treatment

  • Drug: Pembrolizumab 25 mg/ml
  • Drug: Paclitaxel injection

Primary Outcome Measures

  • Distant disease-free survival (DDFS) (5 year)
    Distant disease-free survival is defined as the delay between date of inclusion and distant tumor relapse, second cancer, or death from any cause, whichever occurs first.

Countries

France, Spain

Locations and Investigators

  • Centre Hospitalier De Pau, Pau Cedex, France
    • Kevin, BOURCIER
  • Centre Hospitalier De La Cote Basque, Bayonne, France
    • Thomas, GRELLETY
  • Centre Hospitalier Regional Universitaire De Tours, Tours, France
    • Marie-Agnès, BY
  • Sainte Catherine Institut Du Cancer Avignon-Provence, Avignon Cedex 9, France
    • Julien, GRENIER
  • Pole Sante Republique, Clermont-Ferrand Cedex 2, France
    • Lionel, MOREAU
  • Centre Francois Baclesse, Caen Cedex 5, France
    • George, EMILE
  • Institut Paoli-Calmettes, Marseille, France
    • Frederic, VIRET
  • Institut Universitaire Du Cancer Toulouse-Oncopole, Toulouse Cedex 9, France
    • Florence, DALENC
  • Centre Hospitalier Intercommunal De Cornouaille, Quimper Cedex, France
    • Mathilde, BUREAU
  • Hopital NOVO, Pontoise, France
    • Rolande, NGUEFACK
  • Centr Georges Francois Leclerc, Dijon, France
  • Centre Hospitalier Universitaire De Saint Etienne, St Etienne Cedex 2, France
    • Esma, BOUGHERIRA
  • Centre Hospitalier Et Universitaire De Limoges, Limoges Cedex 1, France
    • Elise, DELUCHE
  • Centre Hospitalier Prive Saint-Gregoire, Saint-Gregoire, France
    • Caroline, CHENEAU
  • Hopital Prive Des Cotes D'armor, Plerin, France
    • Jéröme, MARTIN-BARAU
  • Institut Gustave Roussy, Villejuif, France
    • Elie, RASSY
  • Hopital Prive Jean Mermoz, Lyon, France
    • Olfa, DERBEL
  • Hôpital Franco-Britannique-Fondation Cognacq-Jay, Levallois-Perret, France
    • Nathalie, PEREZ-STAUB
  • Centre Hospitalier Universitaire Amiens Picardie, Amiens Cedex 1, France
    • Aurélie, MOREIRA
  • Centre De Lutte Contre Le Cancer Eugene Marquis, Rennes Cedex, France
    • Fanny, LE DU
  • Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France
    • Nadine, DOHOLLOU
  • Centre Leon Berard, Lyon, France
    • Olivier, TREDAN
  • Centre Antoine Lacassagne, Nice Cedex 2, France
    • Jean-Marc, FERRERO
  • L'Hopital Prive Du Confluent, Nantes Cedex 2, France
    • Dorothée, CHOCTEAU-BOUJU
  • Institut Bergonie, Bordeaux, France
  • Institut Godinot, Reims, France
    • Christelle, JOUANNAUD
  • Centre Hospitalier Universitaire De Nimes, Nimes Cedex 9, France
    • Frederic, FITENI
  • Institut De Cancerologie De Lorraine, Vandoeuvre Les Nancy Cedex, France
    • Anne, KIEFFER
  • Centre Jean Perrin, Clermont Ferrand Cedex1, France
    • Marie-Ange, MOURET-REYNIER
  • Hospital Universitario Ramon Y Cajal, Madrid, Spain
    • Elena, LOPEZ MIRANDA
  • Hospital Clinico Universitario De Valencia, Valencia, Spain
    • JUAN MIGUEL, CEJALVO
  • Hospital Universitari Vall D Hebron, Barcelona, Spain
    • Mafalda, OLIVEIRA
  • ICO L'HOSPITALET HOSPITAL DURAN I REYNALS, Barcelona, Spain
    • SONIA, PERNAS
  • University Hospital Son Espases, Palma, Spain
    • Antonia, PERELLO
  • Hospital Universitario 12 De Octubre, Madrid, Spain
    • Manuel, ALVA BIANCHI
  • Hospital Universitario De Leon, Leon, Spain
    • Ana, LOPEZ
  • Salut Sant Joan De Reus, Reus, Spain
    • ALBA, COCHS
  • University Clinical Hospital Virgen De La Arrixaca, Murcia, Spain
    • PILAR SANCHEZ, HENAREJOS
  • Hospital Clinic De Barcelona, Barcelona, Spain
    • Marta, GONZALEZ RODRIGUEZ
  • Fundacion Instituto Valenciano De Oncologia, Valencia, Spain
    • JOAQUIN, GAVILA GREGORI
  • Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida, Lleida, Spain
  • University Hospital Virgen Del Rocio S.L., Sevilla, Spain
    • MONICA, CEJUELA
  • Institut Catala D'oncologia, Badalona, Spain
    • MARGELI, VILA
  • Hospital Del Mar, Barcelona, Spain
    • Maria, MARTINEZ GARCIA

Study Officials