[Quorum] 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
The purpose of this Phase IIIb study is to collect safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer.
HR+HER2- advanced breast cancer
≥ 18 years of age
hormone receptor-positive (HR+)
HER2-negative (HER2-) advanced breast cancer
No prior hormonal therapy for advanced disease
One prior chemotherapy allowed in the metastatic setting
18 - 120
Healthy Volunteers Needed
Duration of Participation
You will receive the study drug until your disease progresses, you can’t tolerate the treatment, or you and/or your doctor decide to stop treatment.
After you finish treatment your doctor will continue to watch you for side effects and follow your condition until study completion.
OHSU Knight Cancer Institute Information line 503-494-1080
Novartis Pharmaceuticals Corporation