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

NCT07237256 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3902

Last updated 2026-05-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Chemotherapy followed by endocrine therapy and ribociclib treatment

Endocrine therapy and ribociclib treatment

OTHER

De-escalation

De-escalation of the chemotherapy in the adjuvant setting

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • SOLTI Breast Cancer Research Group

    collaborator OTHER

  • GBG Forschungs GmbH

    collaborator OTHER

  • Latin American Cooperative Oncology Group

    collaborator OTHER

  • Gruppo Italiano Mammella (GIM)

    collaborator OTHER

  • BOOG Study Center

    collaborator OTHER

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • Swiss Cancer Institute

    collaborator OTHER

  • Menarini Silicon Biosystems, INC

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • François-Clément BIDARD, PhD · Institut Curie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2033-11-30
Completion
2037-12-31

Countries

  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07237256 on ClinicalTrials.gov