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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
N/A
Open (Enrolling)
Female
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
treatment

- 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
fulvestrant

- 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:

Interventional

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:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBKM120F2302

NCT ID:

NCT01610284

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

Name

Location

Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157
Central Coast Medical Oncology CorporationSanta Maria, California  93454
Florida Oncology Associates Orange ParkJacksonville, Florida  32258
Cancer Care Northwest CC Northwest- Spokane SouthSpokane, Washington  99202
Fairview Southdale Medical Oncology ClinicEdina, Minnesota  55455
Rocky Mountain Cancer Centers RMCC - Denver-MidtownGreenwood Village, Colorado  
Central Indiana Cancer Centers CICC - East (2)Indianapolis, Indiana  46227
Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
St. Jude Heritage Medical Group Virginia Crosson Cancer CenterFullerton, California  92835
Missouri Cancer Associates Dept.ofMissouriCancerAssoc.Columbia, Missouri  65201
Texas Oncology, P.A. MidtownDallas, Texas  75251
Compassionate Cancer Care Medical Group CCCMGFountain Valley, California  92708
Stony Brook University Medical Center Cancer CenterStony 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 CancerBurbank, California  91505-6866
US Oncology Central Monitoring US Oncology Central PharmacyDallas, Texas  75246
Southeast Nebraska Oncology Cancer CenterLincoln, Nebraska  68510
North Shore University Health SystemSkokie, Illinois  60077
Washington University School Of Medicine-Siteman Cancer Ctr Was Univ School of MedSt. Louis, Missouri  63110
University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)Mobile, Alabama  36688
Shapiro & Stafford & Yee & Polanski Study CoordinatorArcadia, California  91007
City of Hope National Medical Center CH Med CtrDuarte, California  91010-3000
Cancer Care Associates Dept.ofCancerCareAssoc.Fresno, California  93720
University of California San Diego UCSD 3La Jolla, California  92093-0658
Coast Hematology Oncology AssociatesLong Beach, California  90806
USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3)Los Angeles, California  90053
Los Angeles Hematology/Oncology Medical Group LA Cancer NetworkLos Angeles, California  90017
Ventura County Hematology and Oncology PMK Medical GroupOxnard, California  93030
Coastal Integrative Cancer CareSan Luis Obispo, California  93401
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*
MD Anderson Cancer Center - Orlando MD OrlandoOrlando, Florida  32806
Georgia Cancer Specialists Georgia CancerDecatur, Georgia  30033
Rush University Medical Center Rush2Chicago, Illinois  60612
Vanguard Health ChicagoChicago, Illinois  60640
Advocate Illinois MasonicMedical Cent/Creticos Cancer Center Dept. of Creticos Cancer CenteChicago, Illinois  60657
Cadence HealthGeneva, Illinois  60134
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
Northwest Cancer Specialists Portland LocPortland, Oregon  97210
St. Luke's Hospital and Health Network St LukeBethlehem, Pennsylvania  
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
Texas Oncology, P.A. TX Onc - Med City DallasDallas, Texas  75251
Texas Oncology, P.A. TX Onc - BedfordDallas, Texas  75251
Texas Oncology, P.A. TX Onc - SouthwestDallas, Texas  75251
Oncology Consultants Oncology ConsultantsHouston, Texas  77024
Texas Oncology P.A. - Plano EastPlano, Texas  75075
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
Mid Dakota Clinic, P.C. Dept of OncologyBismark, North Dakota  58501
Arizona Oncology Associates Dept of OncologyPhoenix, Arizona  
Cancer Care and Hematology Specialists of Chicagoland Niles*see Various Departments*, Illinois  
Massachusetts General Hospital SCBoston, Massachusetts  02114
West Michigan Cancer Center Dept of OncologyKalamazoo, Michigan  49007
Park Nicollet Institute Dept OncSt. Louis Park, Minnesota  55416
Southeast Nebraska OncologyLincoln, Nebraska  68510
Memorial Sloan Kettering Cancer Center Dept OncNew York, New York  10021
Levine Cancer Institute Levine Cancer InstituteCharlotte, North Carolina  28203
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