At a glance
ClinicalIndex Comparison Record- ✓Male or female with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
- ✓Histologically or cytologically confirmed HR+ (ER+ and/or PR+) breast cancer
- ✓HER2-negative breast cancer (ISH negative, or IHC 0/1+, or IHC 2+ with negative FISH/CISH/SISH)
- ✓ECOG performance status ≤2
- ✕Prior CDK4/6 inhibitor therapy
- ✕Prior systemic hormonal therapy for advanced breast cancer
- ✕More than one prior chemotherapy regimen for metastatic disease
- ✕If prior neoadjuvant/adjuvant letrozole or anastrozole, disease-free interval must be >12 months from treatment completion to study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
COMPLEEMENT-1: An Open-label, Multicenter, 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
In Brief
A Phase 3 clinical trial evaluating Ribociclib, Letrozole, and 2 other interventions for Breast Cancer. Completed, enrolled 3,246 participants across 495 sites in 38 countries.
Detailed 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..
Study Details
Timeline
Interventions
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
Letrozole was procured locally and administered orally once a day on a continuous daily schedule at a dose of 2.5 mg
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)
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)