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
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
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).
Inclusion Criteria:
Exclusion Criteria:
Chandler, Arizona 85224, United States
Bakersfield, California 93309, United States
Culver City, California 90232, United States
Fullerton, California 92835, United States
Orange, California 92868, United States
Orange, California 92868, United States
San Francisco, California 94115, United States
San Luis Obispo, California 93401, United States
Torrance, California 90505, United States
Westlake Village, California 91361, United States
Aurora, Colorado 80045, United States
Aurora, Colorado 80045, United States
Deerfield Beach, Florida 33442, United States
Fort Lauderdale, Florida 33308, United States
Austell, Georgia 30106, United States
Cartersville, Georgia 30121, United States
Marietta, Georgia 30060, United States
Zion, Illinois 60099, United States
Brunswick, Maine 04011, United States
Kennebunk, Maine 04043, United States
Scarborough, Maine 04074, United States
Baltimore, Maryland 21231, United States
Lutherville, Maryland 21093, United States
Ann Arbor, Michigan 48109, United States
Minneapolis, Minnesota 55455, United States
Pittsburgh, Pennsylvania 15232, United States
Libramont-Chevigny, Luxembourg 6800, Belgium
Kelowna, British Columbia V1Y 5L3, Canada
Kingston, Ontario K7L 2V7, Canada
Oshawa, Ontario L1G 2B9, Canada
Bagno A Ripoli (FI), 50012, Italy
Bagno A Ripoli (FI), 50012, Italy
Bologna, 40138, Italy
Kita-adachi-gun, Saitama,japan 362-0806, Japan
Sittard-Geleen, Limburg 6162 BG, Netherlands
Tg. Mures, 540142, Romania
Ufa, Bashkortostan Republic 450054, Russia
Stariy Oskol, Belgorod Oblast 309504, Russia
Village Kuzmolovsky, Leningradskaya Oblast' 188663, Russia
Lermontov, Stavropol Territory 357340, Russia
Pyatigorsk, Stavropol Territory 357502, Russia
Chelyabinsk, 454087, Russia
Stavropol, 355047, Russia
Village Pesochny, 197758, Russia
Chernivtsi, 58013, Ukraine
Portsmouth, Hampshire PO6 3LY, United Kingdom
Sheffield, South Yorkshire S10 2SJ, United Kingdom