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Could a pill replace chemo for some breast cancer patients?

NCT ID NCT05296746

Ongoing Disease control Sponsor: SOLTI Breast Cancer Research Group Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether a combination of ribociclib (Kisqali) and letrozole can safely replace chemotherapy for people with high-risk ER+/HER2- breast cancer. About 1100 participants will first receive the drug combo before surgery. If their tumor shows a low risk of recurrence after six months, they continue the same treatment after surgery instead of chemo. The goal is to see if this approach can keep cancer from spreading while avoiding chemo's harsh side effects.

What this could mean

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

Active substance
Ribociclib (Kisqali) plus letrozole
What this could lead to
If successful, this could allow some high-risk breast cancer patients to avoid chemotherapy and its side effects by using a targeted drug combination instead.
What could go wrong
This is a phase 2 trial with 1100 participants, so results are still preliminary. It only applies to patients whose tumors show a low genomic risk after initial treatment, and long-term benefits are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

BREAST CANCER STAGE II

Contacts and locations

Locations

  • Centre Eugène Marquis

    Rennes, France

  • Centre François Baclesse

    Caen, France

  • Centre Georges François Leclerc

    Dijon, France

  • Centre Hospitalier Bretagne Atlantique

    Vannes, France

  • Centre Hospitalier Privé Saint-Grégoire

    Saint-Grégoire, France

  • Centre Hospitalier Universitaire de Besancon

    Besançon, France

  • Centre Hospitalier Universitaire de Grenoble Alpes

    Grenoble, France

  • Centre Hospitalier Universitaire de Limoges

    Limoges, France

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, France

  • Centre Hospitalier de Cholet

    Cholet, France

  • Centre Hospitalier de la Côte Basque

    Bayonne, France

  • Centre Hospitalier les Cornouaille

    Quimper, France

  • Centre Jean Perrin

    Clermont-Ferrand, France

  • Centre Léon Berard

    Lyon, France

  • Centre Oscar lambret

    Lille, France

  • Clinique Mutualiste de l'Estuaire - Groupe HGO

    Saint-Nazaire, France

  • Clinique Pasteur

    Toulouse, France

  • Clinique Sainte Anne - Strasbourg Oncologie Libérale

    Strasbourg, France

  • Complejo Asistencial Universitario de León

    León, Spain

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, Spain

  • Fundación Jiménez Díaz

    Madrid, Spain

  • Gustave Roussy

    Villejuif, France

  • HM Sanchinarro

    Madrid, Spain

  • Hopitaux du Léman

    Thonon-les-Bains, France

  • Hospital 12 de Octubre

    Madrid, Spain

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital Clínico de Valencia

    Valencia, Spain

  • Hospital Ramón y Cajal

    Madrid, Spain

  • Hospital Son Espases

    Palma de Mallorca, Balearic Islands, Spain

  • Hospital Universiatrio Clínico San Cecilio

    Granada, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, Spain

  • Hospital Vall d'Hebron

    Barcelona, Spain

  • Hospital da Luz

    Lisbon, Portugal

  • Hospital de São Francisco Xavier

    Lisbon, Portugal

  • Hôpital Franco Britanique Fondation Cognacq Jay

    Levallois-Perret, France

  • Hôpital Simone veil de Blois

    Blois, France

  • Hôpital privé Jean Mermoz

    Lyon, France

  • Hôpital privé de Confluent

    Nantes, France

  • ICO Badalona

    Badalona, Barcelona, Spain

  • ICO Hospitalet

    L'Hospitalet de Llobregat, Barcelona, Spain

  • IPO Porto

    Porto, Portugal

  • Institut Claudius Regaud, IUCT-Oncopole

    Toulouse, France

  • Institut Curie

    Paris, France

  • Institut Curie

    Saint-Cloud, France

  • Institut Jean Godinot

    Reims, France

  • Institut Paoli Calmettes

    Marseille, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, France

  • Institut de cancérologie Strasbourg Europe - ICANS

    Strasbourg, France

  • Instituto Valenciano de Oncología

    Valencia, Spain

  • Nouvelle Clinique des Dentellières

    Valenciennes, France

  • Sainte Catherine - Institut du Cancer Avignon Provence

    Avignon, France

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