Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

Conditions

• Advanced Metastatic Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 59 Years

Healthy Volunteers

Not accepted

Interventions

• Ribociclib — DRUG
  Ribociclib (600 mg, in three 200 mg hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
• Tamoxifen — DRUG
  Tamoxifen (20 mg, tablets) was administered orally on a continuous daily schedule (days 1-28 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)
• Anastrozole — DRUG
  Anastrozole (1 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
• Goserelin — DRUG
  Goserelin (3.6 mg, subcutaneous implant) was administered on day 1 of every 28-day cycle
• Placebo — DRUG
  Placebo (hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.

Study Details

The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.

Key Dates

Start date

Nov 20, 2014

Status verified

Feb 2024

Primary completion

Aug 21, 2017

Completion

Apr 20, 2023

Study Design

Enrollment

672 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ribociclib + NSAI/tamoxifen + goserelin
  Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
• Placebo Comparator: Placebo + NSAI/tamoxifen + goserelin
  Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days). Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin.

Primary Outcome Measure

Progression Free Survival (PFS) by Investigator Assessment [ Time Frame: From randomization to first documented progression or death, assessed up to approximately 29 months ]

Locations (35)

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