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Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy

NCT07400523 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2026-04-28

No results posted yet for this study

Summary

This is a multi-center, open-lable, prospective, randomized phase III clinical trial to investigate the efficacy and safety of adjuvant ribociclib combined with aromatase inhibitor in hormone receptor-positive, HER2-negative early breast cancer with residual disease after neoadjuvant chemotherapy

Conditions

Interventions

DRUG

Ribociclib plus aromatase inhibitor

Ribociclib (oral 600 mg once daily for 3 weeks on, 1 week off) plus daily aromatase inhibitor (letrozole oral 2·5 mg/day, anastrozole oral 1 mg/day, or exemestane oral 5 mg/day)

DRUG

Aromatase inhibitor

Daily aromatase inhibitor (letrozole oral 2·5 mg/day, anastrozole oral 1 mg/day, or exemestane oral 5 mg/day)

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2030-02-10
Completion
2031-02-10

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT07400523 on ClinicalTrials.gov