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Study identifier: NCT07237256 Synced from ClinicalTrials.gov · August 02, 2026
● Recruiting

Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib

Condition: Breast Cancer  ·  Sponsor: UNICANCER

PhasePhase 3
Planned participants3902
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

The advent of CDK4/6 inhibitors (drugs designed to block the action of CDK4/6 proteins, which play a key role in cell proliferation) has improved treatment prospects for patients with metastatic breast cancer whose tumour cells express hormone receptors but not the HER2 protein (HR+/HER2-). The NATALEE study showed that the addition of ribociclib for three years to conventional adjuvant hormone therapy (i.e. after surgery) prolonged survival free of invasive disease (i.e. extending to surrounding tissues) in patients with early HR breast cancer+ /HER2-. Unlike other studies, NATALEE included a group of patients at intermediate risk of recurrence, usually treated with adjuvant chemotherapy before receiving hormone therapy. However, the benefit of adjuvant chemotherapy in these patients is uncertain. The hypothesis of the NoLEEta study is that by using the CDK 4/6 inhibitor, patients could avoid adjuvant chemotherapy and therefore be spared the side-effects associated with this chemotherapy, without reducing the efficacy of the treatment.

This description comes directly from the study's public registry record.

Talk to the study team

Sandrine Marques  ·  +33 (0) 6 17 90 00 54  ·  s-marques@unicancer.fr

Always discuss trial participation with your own doctor first.

Locations (138)

Clinique de l'EuropeAmiens, FranceNot Yet Recruiting
Institut de Cancérologie de l'Ouest - Site Paul PapinAngers, FranceNot Yet Recruiting
CH Victor DupouyArgenteuil, FranceNot Yet Recruiting
CH Henri MondorAurillac, FranceActive Not Recruiting
Centre Hospitalier d'AuxerreAuxerre, FranceNot Yet Recruiting
Sainte Catherine - Institut du Cancer Avignon ProvenceAvignon, FranceRecruiting
Centre Hospitalier de la Cote BasqueBayonne, FranceActive Not Recruiting
Centre Hospitalier Simone Veil de BeauvaisBeauvais, FranceActive Not Recruiting
Centre Hospitalier Universitaire de BesanconBesançon, FranceNot Yet Recruiting
Institut BergonieBordeaux, FranceNot Yet Recruiting
Clinique TivoliBordeaux, FranceNot Yet Recruiting
Centre Francois BaclesseCaen, FranceNot Yet Recruiting

+ 126 more locations — full list on the registry record.

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