Multicenter, randomized, double-blind, placebo controlled, phase III trial of fulvestrant (Faslodex) with or without PD-0332991 (palbociclib) ± goserelin in women with hormone receptor-positive, HER2-negative metastatic breast cancer whose disease progressed after prior endocrine therapy.

The study was conducted in accordance with legal and regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), Guidelines for Good Clinical Practice (GCP) (International Conference on Harmonisation [ICH] 1996), and the Declaration of Helsinki (World Medical Association 1996 and 2008). In addition, the study was conducted in accordance with the protocol, the ICH guideline on GCP, and applicable local regulatory requirements and laws.