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

Conditions

• Advanced Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ribociclib — DRUG
  Ribociclib capsules were administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle.
• Fulvestrant — DRUG
  Fulvestrant was administered via intramuscular injections at a dose of 500mg every 28 days, starting on Day 1 of each cycle. In Cycle 1, an additional dose of Fulvestrant was given on Day 15.
• Placebo — DRUG
  Placebo capsules were administered orally for 21 consecutive days within a 28-day cycle.

Study Details

The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.

Key Dates

Start date

Jun 9, 2015

Status verified

Nov 2023

Primary completion

Nov 3, 2017

Completion

Jan 11, 2023

Study Design

Enrollment

726 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ribociclib + fulvestrant
  Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. For participants who did not tolerate the protocol-specified dosing schedule, dose adjustments were permitted in order to allow the patient to continue the study treatment.
• Placebo Comparator: Placebo + fulvestrant
  Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. For participants who did not tolerate the protocol-specified dosing schedule, dose adjustments were permitted in order to allow the patient to continue the study treatment. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant.

Primary Outcome Measure

Progression Free Survival (PFS) Per Investigator Assessment [ Time Frame: From randomization to first documented progression or death, assessed up to approximately 26 months ]

Locations (26)

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