RecruitingPhase 3NCT07400523

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

Ribociclib Plus Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy: an Open-label, Multicenter, Randomized, Phase III Trial


Sponsor

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

Enrollment

446 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 clinical trial is testing whether adding ribociclib — a drug that targets cancer cell growth — combined with an aromatase inhibitor improves outcomes for women with hormone receptor-positive, HER2-negative early breast cancer who still had cancer remaining after chemotherapy before surgery. Women aged 18 and older who have completed neoadjuvant chemotherapy and have residual invasive breast cancer may be eligible, provided they have not previously received a CDK4/6 inhibitor and meet specific heart and organ function criteria. Participation involves taking daily oral tablets and attending clinic visits for safety monitoring and imaging scans over several years. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRibociclib 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)

DRUGAromatase inhibitor

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


Locations(3)

Sun Yat-sen Memorial Hospital

Guangzhou, China

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Shantou Central Hospital

Shantou, China

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NCT07400523


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