131
Participants
Start Date
May 31, 2013
Primary Completion Date
March 22, 2017
Study Completion Date
September 12, 2017
Fulvestrant
"Fulvestrant 500 mg Day 1 \& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
Everolimus
"Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
Placebo
Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet.
Beth Israel, New York
Montefiore Medical Center, The Bronx
University of Pittsburgh- Magee Women's Hospital, Pittsburgh
Penn State University, Hershey
Hematology & Oncology Associates of Northeastern PA, PC, Dunmore
Main Line Heath System, Wynnewood
Thomas Jefferson University, Philadelphia
Fox Chase Cancer Center, Philadelphia
Reading Hospital- McGlinn Family Regional Cancer Center, West Reading
Johns Hopkins University, Baltimore
Charleston Area Medical Center (CAMC), Charleston
Ohio State University Medical Center, Columbus
Toledo COP, Toledo
St. Joseph Mercy Hospital (MI Cancer Consortium), Ann Arbor
ProHealth Care Inc. (Waukesha), Waukesha
Aurora Cancer Care, Wauwatosa
St. Vincent Hospital, Green Bay
Gundersen Health System, La Crosse
Metro MN, Saint Louis Park
SwedishAmerican Regional Cancer Center, Rockford
Missouri Valley Cancer Consortium, Omaha
University of Texas Southwestern, Dallas
Stanford University, Stanford
Marin Cancer Care, Greenbrae
McFarland Clinic, PC, Ames
Collaborators (1)
Novartis
INDUSTRY
PrECOG, LLC.
OTHER