Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Active:	No
Cancer Type:	Breast Cancer	NCT ID:	NCT01942135
Trial Phases:	Phase III	Protocol IDs:	A5481023 (primary)
Eligibility:	18 Years and older, Female	Study Type:	Treatment
Study Sponsor:	Pfizer Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT01942135

Summary

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).

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