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

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.

NCT Number	NCT07237256
Lead Sponsor	UNICANCER Collaborators: Novartis, SOLTI Breast Cancer Research Group, GBG Forschungs GmbH, Latin American Cooperative Oncology Group, Gruppo Italiano Mammella (GIM), BOOG Study Center, Canadian Cancer Trials Group, Swiss Cancer Institute, Menarini Silicon Biosystems, INC
Conditions	Breast Cancer
Enrollment	3,902 participants
Start Date	2025-12-18
Primary Completion	2033-11-30 (estimated)
Study Completion	2037-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-26