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Brief Title: Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
Official Title: 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
Study ID: NCT01610284
Brief Summary: This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.
Detailed Description: Patients were randomized (1:1) to receive buparlisib (100 mg/day) or placebo with fulvestrant (500 mg); randomization was stratified by PI3K pathway activation status (activated, non-activated, unknown determined in archival tumor tissue) and visceral disease status (present or absent). Tumor evaluation was performed 6 weeks after the randomization date and then every 8 weeks until radiological progression (based on Response Evaluation Criteria In Solid Tumors \[RECIST\] version 1.1). Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in the program. Accordingly, on 19-Dec-2016, Novartis notified all the Investigators about the decision not to pursue further development of buparlisib in Breast Cancer. As a result, the CBKM120F2302 study was terminated on 19-Apr-2019 (last subject last visit).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2), Mobile, Alabama, United States
Arizona Oncology Associates Dept of Oncology, Phoenix, Arizona, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
Shapiro and Stafford and Yee and Polanski Study Coordinator, Arcadia, California, United States
Cancer Care Associates Dept.ofCancerCareAssoc., Fresno, California, United States
St. Jude Heritage Medical Group Virginia Crosson Cancer Center, Fullerton, California, United States
University of California San Diego - Moores Cancer Center UCSD 3, La Jolla, California, United States
Los Angeles Hematology/Oncology Medical Group LA Cancer Network, Los Angeles, California, United States
USC Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3), Los Angeles, California, United States
University of California at Los Angeles Dept. of UCLA, Los Angeles, California, United States
Ventura County Hematology and Oncology PMK Medical Group, Oxnard, California, United States
Coastal Integrative Cancer Care, San Luis Obispo, California, United States
Santa Barbara Hematolgy Oncology Medical Group, Santa Barbara, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
St Joseph Heritage Healthcare Dept. of RRMG (4), Santa Rosa, California, United States
Granada Hills Cancer Center, Valencia, California, United States
Kaiser Permanente Northwest Kaiser, Denver, Colorado, United States
Rocky Mountain Cancer Centers RMCC, Greenwood Village, Colorado, United States
Memorial Regional Cancer Center MRCC, Hollywood, Florida, United States
Cancer Specialists of North Florida SC - F2302, Jacksonville, Florida, United States
University of Miami Univ Miami 2, Miami, Florida, United States
MD Anderson Cancer Center - Orlando MD Orlando, Orlando, Florida, United States
Georgia Cancer Specialists SC, Decatur, Georgia, United States
North Shore University Health System, Evanston, Illinois, United States
Cadence Health, Geneva, Illinois, United States
Cancer Care and Hematology Specialists of Chicagoland Niles, Multiple Locations, Illinois, United States
Cancer Center of Kansas CCK, Wichita, Kansas, United States
Mercy Medical Center Mercy Medical SC, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Sidney/John Hopkins, Baltimore, Maryland, United States
Frederick Memorial Hospital Fred. Mem. Hosp., Frederick, Maryland, United States
Maryland Oncology Hematology, P.A. SC, Rockville, Maryland, United States
Massachusetts General Hospital SC, Boston, Massachusetts, United States
West Michigan Cancer Center Dept of Oncology, Kalamazoo, Michigan, United States
Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint, Tupelo, Mississippi, United States
Washington University School of Medicine Regulatory, Saint Louis, Missouri, United States
Hackensack Meridian Health, Brick, New Jersey, United States
The Valley Hospital / Luckow Pavillion, Paramus, New Jersey, United States
Clinical Research Alliance SC-2, Lake Success, New York, United States
Memorial Sloan Kettering Dept Onc, New York, New York, United States
University of Rochester Medical Center Univ Rochester, Rochester, New York, United States
Levine Cancer Institute Levine Cancer Institute, Charlotte, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Case Western Reserve SC, Cleveland, Ohio, United States
Northwest Cancer Specialists Portland Loc, Portland, Oregon, United States
St. Luke's Hospital and Health Network St Luke's (2), Bethlehem, Pennsylvania, United States
Charleston Hematology Oncology Association PA, Charleston, South Carolina, United States
Tennessee Cancer Specialists, Knoxville, Tennessee, United States
Vanderbilt University Medical Center Vanderbilt - Thompson Ln, Nashville, Tennessee, United States
Texas Oncology P A Midtown, Dallas, Texas, United States
Texas Oncology P A TX Onc - Bedford, Dallas, Texas, United States
Texas Oncology P A TX Onc - Med City Dallas, Dallas, Texas, United States
Texas Oncology P A TX Onc - Southwest, Dallas, Texas, United States
Oncology Consultants Oncology Consultants, P.A., Houston, Texas, United States
Cancer Therapy and Research Center UT Health Science Center Institute for Drug Development, San Antonio, Texas, United States
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3), Salt Lake City, Utah, United States
Oncology Hematology Associates of Southeast Virginia Salem VA Branch, Roanoke, Virginia, United States
Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc, Kennewick, Washington, United States
West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology, Morgantown, West Virginia, United States
Cancer TEAM Bellin Health Belin Health, Green Bay, Wisconsin, United States
Dean Health System Dean Hematology Oncology, Madison, Wisconsin, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3, Madison, Wisconsin, United States
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Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR