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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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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