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

NCT03671330 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2025-10-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ribociclib Placebo

Film-coated tablets for oral use (200 mg x 3) form Day 1 of 21 of each 28 day cycle.

DRUG

Ribociclib

Film-coated tablets for oral use (200 mg x 3) form Day 1 of 21 of each 28 day cycle.

DRUG

NSAI: Letrozole or Anastrazole

Letrozole: Tablets for oral use, 2.5mg daily (all days of every cycle without interruption). Anastrazole: Tablets for oral use, 1mg daily (all days of every cycle without interruption) For Premenopausal cohort, it is the investigators choice for NSAI based on patients past history. For postmenopausal and PK cohorts, all patients will be on Letrozole.

DRUG

Letrozole

Letrozole: Tablets for oral use, 2.5mg daily (all days of every cycle without interruption).

DRUG

Goserelin

Subcutaneous implant, 3.6mg on Day 1 of each 28 day cycle

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2022-04-25
Completion
2025-05-09

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT03671330 on ClinicalTrials.gov