432
Participants
Start Date
October 3, 2012
Primary Completion Date
May 23, 2016
Study Completion Date
September 21, 2017
Fulvestrant
Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)
BKM120
BKM120 100 mg once daily
BKM120 matching placebo
BKM120 matching placebo, once daily
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Clinical Research Alliance, Lake Success
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University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital, Pittsburgh
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Emory University School of Medicine/Winship Cancer Institute Emory, Atlanta
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University of South Alabama / Mitchell Cancer Institute Univ South AL, Mobile
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Mercy Medical Research Institute SC, Manchester
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Crescent City Research Consortium, LLC SC, Metairie
Lsu Health Sciences Center/ Lsu School of Medicine Lsu, New Orleans
John Ochsner Heart and Vascular Institute Clinical Trials Ochsner 2, New Orleans
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Highlands Oncology Group, Fayetteville
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Texas Oncology PA Dallas Presbyterian Hospital SC, Dallas
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Texas Oncology Texas Oncology - Sammons, Dallas
Texas Oncology P A SC-Austin, Dallas
Texas Oncology P A Texas Oncology - Fort Worth (3, Dallas
University of Texas Southwestern Medical Center, Dallas
US Oncology, P.A., Tyler
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The Methodist Hospital Cancer Center, Houston
Texas Tech University Health Science Center Dept of Texas Tech, El Paso
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Compassionate Cancer Care Medical Group CCCMG, Fountain Valley
Pacific Cancer Care, Monterey
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Moanalua Medical Center. Attn: Oncology Dept, Honolulu
Northwest Cancer Specialists Compass Oncology -BKM, Portland
Oregon Health and Science University SC-5, Portland
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Northwest Medical Specialties, Tacoma
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LSU Health Sciences Center Feist-Weiller Cancer Center, New Orleans
Morristown Memorial Hospital Morristown Mem, Morristown
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Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY