Phase 3 trial Of Fulvestrant with or without Palbociclib +/- Goserelin in women with hormone receptor-positive, Her2-negative metastatic breast cancer whose disease progressed after prior endocrine therapy

Investigator: Hope Rugo, MD
Sponsor: PAREXEL International Corporation

Location(s): United States


The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).