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

Phase 3 Recruiting 446 enrolled Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

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

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ribociclib	Small molecule	600 mg	Oral
Background	Anastrozole	Other / unclassified	1 mg	Oral
Background	Exemestane	Small molecule	5 mg	Oral
Background	Letrozole	Other / unclassified	2.5 mg	Oral

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

Summary

Timeline

Drugs

Indications