Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer

Conditions

• Advanced, Metastatic Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Ribociclib — DRUG
  Ribociclib (600 mg, in three 200 mg hard gelatin capsules or tablets) was administered orally once daily on Days 1-21 of each 28-day cycle.
• Letrozole — DRUG
  Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
• Placebo — DRUG
  Placebo (hard gelatin capsules or tablets) was administered orally once daily on Days 1-21 of each 28-day cycle.

Study Details

The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment for advanced disease.

Key Dates

Start date

Dec 17, 2013

Status verified

Feb 2025

Primary completion

Jan 29, 2016

Completion

Mar 16, 2023

Study Design

Enrollment

668 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ribociclib+ letrozole
  Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
• Placebo Comparator: Placebo + letrozole
  Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole

Primary Outcome Measure

Progression Free Survival (PFS) by Investigator Assessment [ Time Frame: Up to 23 months ]

Locations (73)

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