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The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor–positive, ERBB2-negative breast cancer that progressed on endocrine therapy—MONARCH 2: A randomized clinical trial

JAMA Oncology Oct 04, 2019

Sledge GW, Toi M, Neven P, et al. - In patients with hormone receptor (HR)-positive, ERBB2-negative advanced breast cancer (ABC) that progressed during previous endocrine therapy (ET), researchers assessed overall survival (OS) after treatment with abemaciclib plus fulvestrant or placebo plus fulvestrant at the prespecified interim of MONARCH 2 (338 events)–a global, randomized, placebo-controlled, double-blind phase 3 trial. Patients were randomly allocated 2:1 to receive abemaciclib or placebo, 150 mg, every 12 hours on a continuous schedule plus fulvestrant, 500 mg, per label. They found that irrespective of menopausal status, a statistically significant and clinically meaningful median OS improvement of 9.4 months was brought about by treatment with abemaciclib plus fulvestrant in patients with HR-positive, ERBB2-negative ABC who progressed following previous ET. A substantial delay in the receipt of subsequent chemotherapy was caused by abemaciclib.
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