A Ph 2, Randomized, Double-Blind, Multicenter Study of Exemestane +/- Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer, Progressing on Treatment With a Non-Steroidal AI
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
To compare the efficacy of exemestane alone with exemestane plus entinostat, as determined by the duration of progression free survival (PFS) measured from the date of randomization.
from date of randomization to discontinuation due to disease progression or intolerable AE
No
Denise Yardley, MD
Principal Investigator
Sarah Cannon Cancer Center
United States: Food and Drug Administration
SNDX-275-0301
NCT00676663
May 2008
December 2012
Name | Location |
---|---|
Wake Forest University | Winston-Salem, North Carolina 27103 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
University of Colorado | Denver, Colorado 80217 |
Hematology Oncology Associates | Atlantis, Florida 33462 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
Medical College of Georgia | Augusta, Georgia 30912 |
Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
California Cancer Care | Greenbrae, California 94904 |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Moffitt Cancer Center | Tampa, Florida 33612 |
Allison Cancer Center | Midland, Texas 79701 |
Kansas City Cancer Center | Kansas City, Missouri 64111 |
Indiana University | Indianapolis, Indiana 46202 |
Hematology Oncology Associates | Phoenix, Arizona 85012 |
Longview Cancer Center | Longview, Texas 75601 |
Hematology-Oncology Associates of Northern New Jersey | Morristown, New Jersey 07962 |
Puget Sound Cancer Center | Edmonds, Washington 98026 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee 37404 |
Cancer Care & Hematology Specialists of Chicagoland | Niles, Illinois 60714 |
Greenebaum Cancer Center | Baltimore, Maryland 21201 |
South Texas Cancer Center | Corpus Christi, Texas 78405 |
Columbia Basin Hematology & Oncology | Kennewicke, Washington 99336 |
Memorial Regional | Hollywood, Florida |
Carolinas Healthcare | Charlotte, North Carolina |