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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:August 7, 2012
End Date:March 25, 2019

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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

The purpose of this study is to determine wether the addition of daily BKM120 to fulvestrant
is effective and safe in treating patients with hormone receptor-positive, HER2-negative
locally advanced or metastatic breast cancer refractory to aromatase inhibitor.


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
We found this trial at
61
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Baltimore, Maryland 21202
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220 S Palisade Dr # 204
Santa Maria, California 93454
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Arcadia, CA
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Bethlehem, PA
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Boston, Massachusetts 02114
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Brick, New Jersey 08724
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Caba, Buenos Aires
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Charleston, South Carolina 29414
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Charlotte, North Carolina 28203
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Cleveland, Ohio 44106
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Dallas, Texas 75251
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Decatur, Georgia 30033
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Denver, CO
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Evanston, Illinois 60201
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Fayetteville, Arkansas 72703
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Frederick, MD
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Fresno, CA
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Fullerton, CA
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Geneva, Illinois 60134
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Green Bay, Wisconsin 54313
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Greenwood Village, Colorado
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Hollywood, Florida 33021
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Kalamazoo, MI
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Kennewick, WA
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Knoxville, Tennessee 37920
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La Jolla, CA
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Lake Success, New York 11042
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Miami, Florida 33136
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Mobile, AL
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Morgantown, WV
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8915 West Golf Road
Multiple Locations, Illinois 60714
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Nashville, TN
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641 Lexington Ave
New York, New York 10017
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Orlando, FL
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Oxnard, CA
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Paramus, New Jersey 07652
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Rochester, NY
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Rockville, Maryland 20850
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Saint Louis, Missouri 63110
Principal Investigator: Cynthia X. Ma
Phone: 314-362-7249
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San Luis Obispo, California 93401
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Santa Barbara, California 93105
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Santa Rosa, CA
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Tupelo, MS
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Valencia, California 91355
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Wichita, Kansas 67214
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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