On February 3, 2014 Pfizer reported that the randomized Phase II trial [PALOMA-1] (NCT00721409) of palbociclib achieved its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the combination of palbociclib and letrozole compared with letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or newly diagnosed metastatic breast cancer (Press release Pfizer, FEB 3, 2014, View Source [SID:1234500282]).
Adverse events observed for the palbociclib arm were consistent with the known adverse event profile for this combination. Detailed efficacy and safety data from PALOMA-1 will be submitted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2014 scheduled for April 5-9th in San Diego.

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