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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

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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

Inclusion Criteria:

- Locally advanced or metastatic breast cancer

- HER2-negative and hormone receptor-positive status (common breast cancer
classification tests)

- Postmenopausal woman

- A tumor sample must be shipped to a Novartis designated laboratory for identification
of biomarkers (PI3K activation status)

- Progression or recurrence of breast cancer while on or after aromatase inhibitor

- Measurable disease or non measurable disease bone lesions in the absence of
measurable disease as per RECIST 1.1

- Adequate bone marrow and organ function defined by laboratory values

Exclusion Criteria:

- Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or

- More than one prior chemotherapy line for metastatic disease

- Symptomatic brain metastases

- Increasing or chronic treatment (> 5 days) with corticosteroids or another
immunosuppressive agent

- Active heart (cardiac) disease as defined in the protocol

- Certain scores on an anxiety and depression mood questionnaires

- Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Description:

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.

Outcome Time Frame:

up to approx. 8.3 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

April 2017

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Hormone receptor positive
  • HER2-negative
  • Metastatic
  • Locally advanced
  • PI3K
  • Fulvestrant
  • Refractory
  • Aromatase inhibitor
  • Breast Neoplasms



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