Amanda J Walker, Suparna Wedam, Laleh Amiri-Kordestani, Erik Bloomquist, Shengui Tang, Rajeshwari Sridhara, Wei Chen, Todd R Palmby, Jeanne Fourie Zirkelbach, Wentao Fu, Qi Liu, Amy Tilley, Geoffrey Kim, Paul G Kluetz, Amy E McKee, Richard Pazdur
On February 19, 2016, the FDA approved palbociclib (Ibrance, Pfizer) for use in combination with fulvestrant (Faslodex, AstraZeneca) for the treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer (MBC) with disease progression following endocrine therapy. The approval was based on the results of a randomized, double-blind, placebo-controlled trial conducted in 521 pre- and postmenopausal women with HR-positive, HER2-negative advanced or MBC. Patients were randomized (2:1) to receive palbociclib plus fulvestrant (n = 347) or placebo plus fulvestrant (n = 174)...
October 15, 2016: Clinical Cancer Research