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The Cancer Letter Inc.
PO Box 9905
DC 20016
Tel: 202-362-1809
Fax: 202-379-1787
publication date: Jun 2, 2016
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Breast Cancer

LEE011 Meets Primary Endpoint, Improves PFS in Phase III Trial


An independent data monitoring committee found that a phase III trial of LEE011 (ribociclib) had met its primary endpoint of improving progression-free survival in patients with advanced breast cancer, and recommended that it be stopped early.

The trial, MONALEESA-2, is evaluating LEE011, a cyclin dependent kinase inhibitor (CDK4/6), in combination with letrozole, compared to letrozole alone, in postmenopausal women who had received no prior therapy for HR+/HER2- advanced breast cancer.

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