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Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

NCT02941926 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3246

Last updated 2023-10-24

Study results available
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Summary

The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

Conditions

Interventions

DRUG

Ribociclib

Ribociclib was centrally supplied to the investigators and administered orally once a day on days 1-21 of each 28 day cycle at a starting dose of 600 mg daily

DRUG

Letrozole

Letrozole was procured locally and administered orally once a day on a continuous daily schedule at a dose of 2.5 mg

DRUG

Goserelin

Goserelin was procured locally and administered in men and premenopausal women as an injectable subcutaneous implant administered on day 1 starting at Cycle 1 and then every 28 days at a dose of 3.6 mg (cycle = 28 days)

DRUG

Leuprolide

Leuprolide was procured locally and administered in men and premenopausal women as an injectable intramuscular depot administered on day 1 starting at Cycle 1 and then every 28 days at a dose of 7.5 mg (cycle= 28 days)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-11-08
Completion
2022-11-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Jordan
  • Lebanon
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Oman
  • Panama
  • Philippines
  • Poland
  • Portugal
  • Russia
  • Saudi Arabia
  • Singapore
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

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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 NCT02941926 on ClinicalTrials.gov