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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03671330
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib Placebo — DRUG
    Film-coated tablets for oral use (200 mg x 3) from days 1 to 21 of each 28 day cycle.
  • Ribociclib — DRUG
    Film-coated tablets for oral use (200 mg x 3) from days 1 to 21 of each 28 day cycle.
  • NSAI: Letrozole or Anastrazole — DRUG
    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.
  • Goserelin — DRUG
    Subcutaneous implant, 3.6mg on Day 1 of each 28 day cycle

Study Details

This was a randomized, double-blind, placebo-controlled study conducted in Chinese women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, plus an open-label, single-arm pharmacokinetic (PK) subset in postmenopausal Chinese women with HR+, HER2- advanced breast cancer.

Key Dates

First listed
Sep 14, 2018
Start date
Aug 29, 2018
Status verified
Jun 2026
Primary completion
Apr 25, 2022
Completion
May 9, 2025

Study Design

Enrollment
327 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib
    Patients in premenopausal and postmenopausal cohorts were randomized in a 1:1 ratio to either the experimental arm or the control arm. Premenopausal experimental arm: Non-steroidal aromatase inhibitor (NSAI) + Goserelin + Ribociclib. For premenopausal patients only, the patient was an adult female who was ≥ 18 years old and \< 60 years old at the time of providing informed consent. The choice of non-steroidal aromatase inhibitor was based on the investigator's assessment of the patient's past medical history. Postmenopausal experimental arm: Letrozole + Ribociclib. Pharmacokinetic (PK) Cohort: Open-label treatment with Ribociclib + Letrozole combination. For postmenopausal patients only, the patient was an adult female who was ≥ 18 years old at the time of providing informed consent.
  • Placebo Comparator: Ribociclib Placebo
    Patients in premenopausal and postmenopausal cohorts were randomized in a 1:1 ratio to either the experimental arm or the control arm. Premenopausal control arm: Non-steroidal aromatase inhibitor (NSAI) + Goserelin + Placebo. For premenopausal patients only, the patient was an adult female who was ≥ 18 years old and \< 60 years old at the time of providing informed consent. The choice of non-steroidal aromatase inhibitor was based on the investigator's assessment of the patient's past medical history. Postmenopausal control arm: Letrozole + Placebo. For postmenopausal patients only, the patient was an adult female who was ≥ 18 years old at the time of providing informed consent.

Primary Outcome Measure

Pre and Postmenopausal Cohorts: Progressive Free Survival (PFS) Based on Local Assessment by RECIST 1.1 Guideline [ Time Frame: After approximately 100 progression-free survival (PFS) events had been observed in each cohort, using data collected up to the analysis cut-off date of 25-Apr-2022, an average of 43 months. ]

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