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

NCT02422615 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 726

Last updated 2023-11-30

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Ribociclib

Ribociclib capsules were administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle.

DRUG

Fulvestrant

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.

DRUG

Placebo

Placebo capsules were administered orally for 21 consecutive days within a 28-day cycle.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-09
Primary Completion
2017-11-03
Completion
2023-01-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Jordan
  • Lebanon
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02422615 on ClinicalTrials.gov