A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment
Interventional
Allocation: Randomized, Endpoint Classification: 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 time from date of randomization to the date of the event, defined as 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 randomization.
Up to approx. 5.5 months
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CBKM120F2303
NCT01633060
October 2012
October 2016
Name | Location |
---|---|
Kaiser Permanente Hawaii | Honolulu, Hawaii 96819 |
Northeast Georgia Cancer Care | Athens, Georgia 30607 |
Northwest Cancer Specialists Vancouver Location | Portland, Oregon 97210 |
US Oncology Central Monitoring | Dallas, Texas 75246 |
Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville, Arkansas 72703 |
Texas Oncology, P.A. Central Austin Cancer Center | Dallas, Texas 75251 |
The West Clinic Dept. of the West Clinic | Memphis, Tennessee 38120 |
Texas Oncology, P.A. Texas Oncology - Sammons | Dallas, Texas 75246 |
Compassionate Cancer Care Medical Group CCCMG | Fountain Valley, California 92708 |
Pacific Cancer Care | Salinas, California 93901 |
Washington University School Of Medicine-Siteman Cancer Ctr SC | St. Louis, Missouri 63110 |
University of South Alabama / Mitchell Cancer Institute Univ South AL | Mobile, Alabama 36688 |
Cedars Sinai Medical Center Cedars 2 | Los Angeles, California 90048 |
Emory University School of Medicine/Winship Cancer Institute Emory | Atlanta, Georgia 30322 |
Hematology and Oncology Specialists SC | Metairie, Louisiana 70006 |
Ochsner Clinic Foundation Ochsner 2 | New Orleans, Louisiana 70121 |
University of Maryland Medical Center Univ Maryland | Baltimore, Maryland 21201 |
Holy Cross Hospital Holy Cross | Silver Spring, Maryland 20910 |
University of Texas Southwestern Medical Center UT Southwestern 2 | Dallas, Texas 75390-8527 |
Mercy Medical Research Institute SC | Manchester, Missouri 63021 |
Case Western Reserve SC | Cleveland, Ohio 44106-5000 |
University of California at Los Angeles UCLA SC | Los Angeles, California 90095 |
Edward Hospital Edward Hospital | Naperville, Illinois 60540 |
Cancer Center of Kansas Dept.ofCancerCtr.ofKansas | Wichita, Kansas 67214-3728 |
Lsu Health Sciences Center/ Lsu School of Medicine Lsu | New Orleans, Louisiana 70115 |
Morristown Memorial Hospital Morristown Mem | Morristown, New Jersey 07962 |
CINJ at Cooper University Hospital Dept of Onc | Voorhees, New Jersey 08043 |
Montefiore Medical Center Montefiore | Bronx, New York 10467 |
Oregon Health & Science University SC-5 | Portland, Oregon 97239 |
University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital | Pittsburgh, Pennsylvania 15232 |
Avera Research Institute Avera SC | Sioux Falls, South Dakota 57105 |
Texas Oncology, P.A. Texas Oncology - Fort Worth (3 | Dallas, Texas 75251 |
Texas Tech University Health Science Center Dept of Texas Tech | El Paso, Texas 79905 |
The Baylor College of Medicine/The Methodist Hospital Methodist | Houston, Texas 77030 |