NCT07400523

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 446 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-02-10
• Primary completion: 2030-02-10
• Completion: 2031-02-10
• First posted: 2026-02-10
• Last updated: 2026-04-17

Locations

3 sites across 1 country: China