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

Official Title

COMPLEEMENT-1: An Open-label, Multicentre, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease

Summary:

The purpose of this Phase IIIb 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.

Trial Description

Primary Outcome:

  • The number of participants with adverse events as a measure of safety and tolerability
Secondary Outcome:
  • Time-to-Progression (TTP)
  • Overall response rate (ORR) for patients with measurable disease
  • Clinical Benefit Rate (CBR)
  • Patient Reported Outcome (PRO) using scores from FACT-B questionaire

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society