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PALOMA-2: IBRANCE plus Letrozole Patients with estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine-based therapy The safety of IBRANCE plus letrozole was evaluated in a randomized, double-blind trial (PALOMA-2) in 666 patients with ER-positive, HER2-negative advanced breast cancer [see Clinical Studies (14.1)]