A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression free survival (PFS)
PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 8 weeks after randomisation.
up to approx. 8.3 months
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CBKM120F2302
NCT01610284
February 2012
April 2017
Name | Location |
---|---|
Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157 |
Central Coast Medical Oncology Corporation | Santa Maria, California 93454 |
Florida Oncology Associates Orange Park | Jacksonville, Florida 32258 |
Cancer Care Northwest CC Northwest- Spokane South | Spokane, Washington 99202 |
Fairview Southdale Medical Oncology Clinic | Edina, Minnesota 55455 |
Rocky Mountain Cancer Centers RMCC - Denver-Midtown | Greenwood Village, Colorado |
Central Indiana Cancer Centers CICC - East (2) | Indianapolis, Indiana 46227 |
Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville, Arkansas 72703 |
St. Jude Heritage Medical Group Virginia Crosson Cancer Center | Fullerton, California 92835 |
Missouri Cancer Associates Dept.ofMissouriCancerAssoc. | Columbia, Missouri 65201 |
Texas Oncology, P.A. Midtown | Dallas, Texas 75251 |
Compassionate Cancer Care Medical Group CCCMG | Fountain Valley, California 92708 |
Stony Brook University Medical Center Cancer Center | Stony Brook, New York 11794 |
Redwood Regional Medical Group - Santa Rosa Dept. of RRMG (4) | Santa Rosa, California 94503 |
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3) | Salt Lake City, Utah 84103 |
Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer | Burbank, California 91505-6866 |
US Oncology Central Monitoring US Oncology Central Pharmacy | Dallas, Texas 75246 |
Southeast Nebraska Oncology Cancer Center | Lincoln, Nebraska 68510 |
North Shore University Health System | Skokie, Illinois 60077 |
Washington University School Of Medicine-Siteman Cancer Ctr Was Univ School of Med | St. Louis, Missouri 63110 |
University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2) | Mobile, Alabama 36688 |
Shapiro & Stafford & Yee & Polanski Study Coordinator | Arcadia, California 91007 |
City of Hope National Medical Center CH Med Ctr | Duarte, California 91010-3000 |
Cancer Care Associates Dept.ofCancerCareAssoc. | Fresno, California 93720 |
University of California San Diego UCSD 3 | La Jolla, California 92093-0658 |
Coast Hematology Oncology Associates | Long Beach, California 90806 |
USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3) | Los Angeles, California 90053 |
Los Angeles Hematology/Oncology Medical Group LA Cancer Network | Los Angeles, California 90017 |
Ventura County Hematology and Oncology PMK Medical Group | Oxnard, California 93030 |
Coastal Integrative Cancer Care | San Luis Obispo, California 93401 |
Santa Barbara Hematolgy Oncology Medical Group | Santa Barbara, California 93105 |
Granada Hills Cancer Center | Valencia, California 91355 |
Kaiser Permanente Northwest Kaiser | Denver, Colorado |
St. Mary's Cancer Center St Mary's | Grand Junction, Colorado 81502 |
Norwalk Hospital Whittingham Cancer Ctr. | Norwalk, Connecticut 06856 |
Memorial Regional Cancer Center MRCC | Hollywood, Florida 33021 |
Cancer Center of South Florida | Lake Worth, Florida 33461 |
University of Miami Univ Miami 2 | Miami, Florida 33136 |
Cancer Centers of Florida PA Cancer Center of Florida | Ocoee, Florida *see dep* |
MD Anderson Cancer Center - Orlando MD Orlando | Orlando, Florida 32806 |
Georgia Cancer Specialists Georgia Cancer | Decatur, Georgia 30033 |
Rush University Medical Center Rush2 | Chicago, Illinois 60612 |
Vanguard Health Chicago | Chicago, Illinois 60640 |
Advocate Illinois MasonicMedical Cent/Creticos Cancer Center Dept. of Creticos Cancer Cente | Chicago, Illinois 60657 |
Cadence Health | Geneva, Illinois 60134 |
Cancer Center of Kansas CCK | Wichita, Kansas 67214-3728 |
University of Louisville / James Graham Brown Cancer Center SC | Louisville, Kentucky 40202 |
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Sidney/John Hopkins | Baltimore, Maryland 21231 |
Mercy Medical Center Mercy Medical SC | Baltimore, Maryland 21202 |
Frederick Memorial Hospital Fred. Mem. Hosp. | Frederick, Maryland 21701 |
Associates in Oncology/Hematology, P.C. SC | Rockville, Maryland 20850 |
Hematology and Oncology Association at Bridgepoint Hem Onc Bridgeport | Tupeol, Mississippi 38801 |
Research Medical Center Reseach Med Ctr | Kansas City, Missouri 64132 |
Meridian Health Systems | Brick, New Jersey 08724 |
The Valley Hospital / Luckow Pavillion | Paramus, New Jersey 07652 |
Arena Oncology Associates, PC SC | Lake Success, New York 11042 |
Weill Cornell Medical Center Weill Cornell Breast Center | New York, New York 10021 |
University of Rochester Medical Center Univ Rochester | Rochester, New York 14642 |
Cancer Care of the Cascades St. Charles Medical Center | Bend, Oregon 97701 |
Northwest Cancer Specialists Portland Loc | Portland, Oregon 97210 |
St. Luke's Hospital and Health Network St Luke | Bethlehem, Pennsylvania |
Penn State University / Milton S. Hershey Medical Center Division of Oncology | Hershey, Pennsylvania 17033-0850 |
Abington Hematology Oncology Associates, Inc Abington Hem Onc | Willow Grove, Pennsylvania 19090 |
Charleston Hematology Oncology Association PA | Charleston, South Carolina 29414 |
Tennessee Cancer Specialists Center for Biomedical Research | Knoxville, Tennessee 37909 |
Vanderbilt University Medical Center Vanderbilt - Thompson Ln | Nashville, Tennessee 37232 |
Texas Oncology, P.A. TX Onc - Med City Dallas | Dallas, Texas 75251 |
Texas Oncology, P.A. TX Onc - Bedford | Dallas, Texas 75251 |
Texas Oncology, P.A. TX Onc - Southwest | Dallas, Texas 75251 |
Oncology Consultants Oncology Consultants | Houston, Texas 77024 |
Texas Oncology P.A. - Plano East | Plano, Texas 75075 |
Cancer Therapy & Research Center / UT Health Science Center Institute for Drug Development | San Antonio, Texas 78229 |
Columbia Basin Hematology Columbia Basin | Kennewick, Washington 99336 |
Cancer TEAM Bellin Health Belin Health | Green Bay, Wisconsin 54313 |
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3 | Madison, Wisconsin 53792-6164 |
Dean Health System Dean Hematology Oncology | Madison, Wisconsin 53717 |
University of California at Los Angeles Dept. of UCLA | Los Angeles, California 90095 |
Mid Dakota Clinic, P.C. Dept of Oncology | Bismark, North Dakota 58501 |
Arizona Oncology Associates Dept of Oncology | Phoenix, Arizona |
Cancer Care and Hematology Specialists of Chicagoland Niles | *see Various Departments*, Illinois |
Massachusetts General Hospital SC | Boston, Massachusetts 02114 |
West Michigan Cancer Center Dept of Oncology | Kalamazoo, Michigan 49007 |
Park Nicollet Institute Dept Onc | St. Louis Park, Minnesota 55416 |
Southeast Nebraska Oncology | Lincoln, Nebraska 68510 |
Memorial Sloan Kettering Cancer Center Dept Onc | New York, New York 10021 |
Levine Cancer Institute Levine Cancer Institute | Charlotte, North Carolina 28203 |
Case Western Reserve SC | Cleveland, Ohio 44106-5000 |
Western Pennsylvania Cancer Institute /Western Penn Hospital Dept Onc | Pittsburgh, Pennsylvania 15224 |
Oncology Hematology Associates of Southeast Virginia Salem VA Branch | Roanoke, Virginia 24014 |
West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology | Morgantown, West Virginia 26506 |