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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



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University of California San Diego UCSD 3La Jolla, California  92093-0658
Coast Hematology Oncology AssociatesLong Beach, California  90806
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Los Angeles Hematology/Oncology Medical Group LA Cancer NetworkLos Angeles, California  90017
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Santa Barbara Hematolgy Oncology Medical GroupSanta Barbara, California  93105
Granada Hills Cancer CenterValencia, California  91355
Kaiser Permanente Northwest KaiserDenver, Colorado  
St. Mary's Cancer Center St Mary'sGrand Junction, Colorado  81502
Norwalk Hospital Whittingham Cancer Ctr.Norwalk, Connecticut  06856
Memorial Regional Cancer Center MRCCHollywood, Florida  33021
Cancer Center of South FloridaLake Worth, Florida  33461
University of Miami Univ Miami 2Miami, Florida  33136
Cancer Centers of Florida PA Cancer Center of FloridaOcoee, Florida  *see dep*
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Cancer Center of Kansas CCKWichita, Kansas  67214-3728
University of Louisville / James Graham Brown Cancer Center SCLouisville, Kentucky  40202
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Sidney/John HopkinsBaltimore, Maryland  21231
Mercy Medical Center Mercy Medical SCBaltimore, Maryland  21202
Frederick Memorial Hospital Fred. Mem. Hosp.Frederick, Maryland  21701
Associates in Oncology/Hematology, P.C. SCRockville, Maryland  20850
Hematology and Oncology Association at Bridgepoint Hem Onc BridgeportTupeol, Mississippi  38801
Research Medical Center Reseach Med CtrKansas City, Missouri  64132
Meridian Health SystemsBrick, New Jersey  08724
The Valley Hospital / Luckow PavillionParamus, New Jersey  07652
Arena Oncology Associates, PC SCLake Success, New York  11042
Weill Cornell Medical Center Weill Cornell Breast CenterNew York, New York  10021
University of Rochester Medical Center Univ RochesterRochester, New York  14642
Cancer Care of the Cascades St. Charles Medical CenterBend, Oregon  97701
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Penn State University / Milton S. Hershey Medical Center Division of OncologyHershey, Pennsylvania  17033-0850
Abington Hematology Oncology Associates, Inc Abington Hem OncWillow Grove, Pennsylvania  19090
Charleston Hematology Oncology Association PACharleston, South Carolina  29414
Tennessee Cancer Specialists Center for Biomedical ResearchKnoxville, Tennessee  37909
Vanderbilt University Medical Center Vanderbilt - Thompson LnNashville, Tennessee  37232
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Oncology Consultants Oncology ConsultantsHouston, Texas  77024
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Cancer Therapy & Research Center / UT Health Science Center Institute for Drug DevelopmentSan Antonio, Texas  78229
Columbia Basin Hematology Columbia BasinKennewick, Washington  99336
Cancer TEAM Bellin Health Belin HealthGreen Bay, Wisconsin  54313
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3Madison, Wisconsin  53792-6164
Dean Health System Dean Hematology OncologyMadison, Wisconsin  53717
University of California at Los Angeles Dept. of UCLALos Angeles, California  90095
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Park Nicollet Institute Dept OncSt. Louis Park, Minnesota  55416
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Case Western Reserve SCCleveland, Ohio  44106-5000
Western Pennsylvania Cancer Institute /Western Penn Hospital Dept OncPittsburgh, Pennsylvania  15224
Oncology Hematology Associates of Southeast Virginia Salem VA BranchRoanoke, Virginia  24014
West Virginia University/ Mary Babb Randolph Cancer Center Dept of OncologyMorgantown, West Virginia  26506