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Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

NCT05296746 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2026-05-14

No results posted yet for this study

Summary

This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole.

This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting.

Conditions

  • Breast Cancer Stage II

Interventions

DRUG

Ribociclib (neoadjuvant)

Ribociclib 600 mg/day + letrozole during neoadjuvant phase.

DRUG

Chemotherapy (adjuvant)

Adjuvant chemotherapy. 3 regimens are permitted.

DRUG

Ribociclib (adjuvant)

Ribociclib 400 mg/day + letrozole (or other aromatase inhibitor) during adjuvant phase.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • UNICANCER

    collaborator OTHER

  • SOLTI Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Aleix Prat, MD · Hospital Clínic de Barcelona/SOLTI

  • Paul Cottu, MD · Institut Curie Paris

  • Joaquín Gavilá, MD · Instituto Valenciano de Oncología

  • Thibault de La Motte Rouge, MD · Centre Eugène Marquis, Rennes

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2029-10-01
Completion
2031-12-01

Countries

  • France
  • Portugal
  • Spain

Study Locations

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Entities

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 NCT05296746 on ClinicalTrials.gov