ABCSG 46/CompLEEment-1 Summary

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.

Start: 05/2017
Coordinating Investigator: Bartsch, Rupert; Wien
Sample size: 3.000 (international), 30 (national)
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ABCSG 46/CompLEEment-1.