Overview

Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.

Status:
Active, not recruiting

Trial end date:
2023-12-13

Target enrollment:

Participant gender:

Summary

This is a Phase II randomized, double-blind, placebo-controlled study involving premenopausal and postmenopausal Chinese women plus an open-label single arm of pharmacokinetic cohort of LEE011 in combination with Letrozole in Chinese postmenopausal women with HR+, HER2- negative advanced breast cancer. Three cohorts of patients will be enrolled: PK cohort, premenopausal cohort, and postmenopausal cohort.

Phase:

Phase 2

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Anastrozole
Goserelin
Letrozole