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) form Day 1 of 21 of each 28 day cycle.
  • Ribociclib — DRUG
    Film-coated tablets for oral use (200 mg x 3) form Day 1 of 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.
  • Letrozole — DRUG
    Letrozole: Tablets for oral use, 2.5mg daily (all days of every cycle without interruption).
  • Goserelin — DRUG
    Subcutaneous implant, 3.6mg on Day 1 of each 28 day cycle

Study Details

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.

Key Dates

Start date
Aug 29, 2018
Status verified
Oct 2025
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 pre- and postmenopausal cohorts will be randomized in the 1:1 ratio to the experimental arm or the control arm. Premenopausal experimental arm: NSAI + Goserelin + Ribociclib; For pre-menopausal only, patient is an adult, female ≥ 18 years old and \< 60 years old at the time of informed consent. It is the investigators choice for NSAI based on patient's past medical history. Postmenopausal experimental arm: Letrozole + Ribociclib PK Cohort: Open-label ribociclib + Letrozole treatment combination. For postmenopausal only, patient is an adult, female ≥ 18 years old at the time of informed consent
  • Placebo Comparator: Ribociclib Placebo
    Patients in pre- and postmenopausal cohorts will be randomized in the 1:1 ratio to the experimental arm or the control arm. Premenopausal control arm: NSAI + Goserelin + Placebo; For pre-menopausal only, patient is an adult, female ≥ 18 years old and \< 60 years old at the time of informed consent. It is the investigators choice for NSAI based on patient's past medical history. Postmenopausal control arm: Letrozole + Placebo For postmenopausal only, patient is an adult, female ≥ 18 years old at the time of informed consent

Primary Outcome Measure

Progressive free survival (PFS) based on local assessment by RECIST 1.1 guideline [ Time Frame: The primary analysis will be conducted for pre and postmenopausal cohorts separately when approximately 100 PFS events have been observed in pre- and postmenopausal cohorts (approximately 23 months). ]

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