IRB #

STUDY00017016

Title

[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

Principal Investigator

Zahi Mitri

Study Purpose

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.

Medical Condition(s)

HR+HER2- advanced breast cancer

Eligibility Criteria

≥ 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

Age Range

18 - 120

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

OHSU Knight Cancer Institute Information line 503-494-1080

Sponsor

Novartis Pharmaceuticals Corporation

Recruitment End

11/30/2020

Compensation Provided

No


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