a study on Breast Cancer
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).
Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Trial Of Fulvestrant (Faslodex (Registered)). 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
Metastatic Breast Cancer Palbociclib (PD-0332991) Fulvestrant Goserelin Hormone receptor-+ HER2-negative Prior Endocrine treatment any menopausal status PALOMA-3 Hormones Estradiol Palbociclib
Open to females ages 18 years and up
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