Can less chemo be enough? new trial tailors treatment for early breast cancer

NCT ID NCT06078384

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase 2 trial is for people with early-stage triple-negative breast cancer that has a high level of immune cells (TILs) in the tumor. It tests whether some patients can safely skip chemotherapy and just be monitored, while others receive a combination of the immunotherapy drug pembrolizumab (Keytruda) and a low dose of the chemo drug paclitaxel. The goal is to see if this personalized approach can prevent the cancer from coming back while reducing unnecessary treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Pembrolizumab (Keytruda) and Paclitaxel (Taxol)
What this could lead to
If successful, this could show that some patients with early-stage triple-negative breast cancer can safely receive less chemotherapy or even avoid it, reducing side effects while maintaining good outcomes.
What could go wrong
This is a mid-stage trial with only 354 participants, so results may not apply to all patients. The approach may not prevent cancer from returning, and pembrolizumab can cause immune-related side effects.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHU Amiens Picardie_Site Sud

    RECRUITING

    Amiens, 80054, France

  • CHU Bretonneau

    RECRUITING

    Tours, 37000, France

  • CHU de Limoges

    RECRUITING

    Limoges, 87042, France

  • CHU de Nîmes

    RECRUITING

    Nîmes, 30029, France

  • CHU de Saint Etienne

    RECRUITING

    Saint-Etienne, 42055, France

  • Centre Alexis Vautrin

    RECRUITING

    Vandœuvre-lès-Nancy, 54519, France

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, 61000, France

  • Centre Eugène Marquis

    RECRUITING

    Rennes, 35000, France

  • Centre François Baclesse

    RECRUITING

    Caen, 14000, France

  • Centre Georges-François Leclerc

    NOT_YET_RECRUITING

    Dijon, 21000, France

  • Centre Hospitalier de Cornouaille

    RECRUITING

    Quimper, 29107, France

  • Centre Hospitalier de Pau

    RECRUITING

    Pau, 64046, France

  • Centre Hospitalier de la Côte Basque

    RECRUITING

    Bayonne, 64109, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, 63011, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69008, France

  • Clinique La Croix du Sud

    WITHDRAWN

    Quint-Fonsegrives, 31130, France

  • Complejo Asistencial Universitario de Leon

    NOT_YET_RECRUITING

    León, 24071, Spain

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Hopital Privé Jean Mermoz

    RECRUITING

    Lyon, 69008, France

  • Hospital 12 de Octubre

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

  • Hospital Clinico Universitario Virgen de La Arrixaca

    NOT_YET_RECRUITING

    El Palmar, 30120, Spain

  • Hospital Clínico Valencia

    NOT_YET_RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario Dr.Balmis

    NOT_YET_RECRUITING

    Alicante, Spain

  • Hospital Ramon Y Cajal

    NOT_YET_RECRUITING

    Madrid, 28034, Spain

  • Hospital Sant Joan de Reus

    NOT_YET_RECRUITING

    Reus, 43204, Spain

  • Hospital Universitari Son Espases

    NOT_YET_RECRUITING

    Palma de Mallorca, 07120, Spain

  • Hospital Universitario Clinico San Cecilio

    NOT_YET_RECRUITING

    Granada, 18016, Spain

  • Hospital Universitario Virgen Del Rocio

    NOT_YET_RECRUITING

    Seville, 41013, Spain

  • Hospital Vall D'Hebrón

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • Hu Arnau de Vilanova Lleida

    NOT_YET_RECRUITING

    Lleida, 25198, Spain

  • Hôpital Franco-Britannique-Fondation Cognacq-Jay

    NOT_YET_RECRUITING

    Levallois-Perret, 92300, France

  • Hôpital NOVO

    RECRUITING

    Pontoise, 95300, France

  • Hôpital Privé des côtes d'Armor

    NOT_YET_RECRUITING

    Plérin, 22190, France

  • Hôpital privé du confluent

    RECRUITING

    Nantes, 44200, France

  • Ico Badalona

    NOT_YET_RECRUITING

    Badalona, 08916, Spain

  • Ico Hospitalet

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Institut Bergonié

    NOT_YET_RECRUITING

    Bordeaux, 33000, France

  • Institut Claudius Regaud

    RECRUITING

    Toulouse, 31059, France

  • Institut Godinot

    RECRUITING

    Reims, 51100, France

  • Institut Paoli-Calmettes

    RECRUITING

    Marseille, 13009, France

  • Institut Sainte Catherine

    RECRUITING

    Avignon, 84918, France

  • Institut régional du Cancer de Montpellier

    NOT_YET_RECRUITING

    Montpellier, 34298, France

  • Polyclinique Bordeaux Nord Aquitaine

    RECRUITING

    Bordeaux, 33077, France

  • Pôle Santé Republique

    RECRUITING

    Clermont-Ferrand, 63000, France

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