Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:June 2013
End Date:March 2020

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A PHASE 2, SINGLE-ARM, OPEN-LABEL, MULTICENTER STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF ENZALUTAMIDE IN PATIENTS WITH ADVANCED, ANDROGEN RECEPTOR-POSITIVE, TRIPLE-NEGATIVE BREAST CANCER

The purpose of this study is to determine if enzalutamide is safe and effective in the
treatment of patients with advanced breast cancer that express the androgen receptor but do
not express the estrogen or progesterone receptor and are not Her2 amplified.


Inclusion Criteria:

- Women at least 18 years of age;

- Advanced AR+ TNBC;

- Availability of a representative tumor specimen:

- Either measurable disease or bone only nonmeasurable disease;

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

- Any severe concurrent disease, infection, or comorbid condition;

- Any condition or reason that interferes with the patient's ability to participate in
the trial, that may cause undue risk, or complicates the interpretation of safety
data;

- Current or previously treated brain metastasis or active leptomeningeal disease;

- Current hormone replacement therapy;

- Local palliative radiation therapy within 7 days before day 1;

- History of another invasive cancer within 5 years of day 1;

- Absolute neutrophil count < 1500/µL, platelet count < 75,000/µL, or hemoglobin < 9
g/dL (5.6 mmol/L) at the screening visit;

- Creatinine > 1.5 times upper limit of normal (ULN) at the screening visit;

- History of seizure or any condition that may predispose to seizure;

- Clinically significant cardiovascular disease;

- Active gastrointestinal disorder affecting absorption;

- Major surgery within 4 weeks before day 1;

- Treatment with any commercially available anticancer agent within 14 days before day
1;

- Treatment with any investigational agent within 2 weeks before day 1;

- Treatment with any of the following medications within 2 weeks before day 1:
Estrogens, including hormone replacement therapy; Androgens (testosterone,
dihydroepiandrosterone, etc);Systemic radionuclides (eg, samarium or
strontium);Vaccine therapy;

- Hypoglycemic episode requiring medical intervention while on insulin treatment within
12 months before day 1;

- Hypersensitivity reaction to the active pharmaceutical ingredient or any of the
capsule components, including Labrasol, butylated hydroxyanisole, and butylated
hydroxytoluene.
We found this trial at
79
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
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601 East Altamonte Drive
Altamonte Springs, Florida 32701
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Bonita Springs, Florida 34135
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Bradenton, Florida 34209
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403 South Kings Avenue
Brandon, Florida 33511
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Cape Coral, Florida 33914
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Chicago, Illinois 60611
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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3280 McMullen Booth Road
Clearwater, Florida 33761
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Colorado Springs, Colorado 80907
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Corinth, Mississippi 38834
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Crestview Hills, Kentucky 41017
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Dickson, Tennessee 37055
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Fairfield, Ohio 45014
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Franklin, Tennessee 37067
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Gainesville, Florida
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Gallatin, Tennessee 37066
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501 N. Elam Avenue
Greensboro, North Carolina 27403
336-832-1100
Cone Health Cancer Center Located adjacent to Wesley Long Hospital, our Cone Health Cancer Center...
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Greensboro, North Carolina
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Greenville, South Carolina 29615
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Hermitage, Tennessee 37076
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7651 Medical Drive
Hudson, Florida 34667
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Indianapolis, Indiana 46202
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Indianapolis, Indiana 46202
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Indianapolis, Indiana 46202
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Indianapolis, Indiana 46290
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Lakewood, Colorado 80228
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1301 2nd Avenue Southwest
Largo, Florida 33770
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Lebanon, Tennessee 37087
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Lone Tree, Colorado 80124
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Mechanicsville, Virginia
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100 N Humphreys Blvd
Memphis, Tennessee 38120
(901) 683-0055
The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
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Midlothian, Virginia
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Morristown, New Jersey 07960
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Murfreesboro, Tennessee 37130
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Naples, Florida 34102
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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719 Thompson Lane
Nashville, Tennessee 37204
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Nashville, Tennessee 37232
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New Port Richey, Florida 34655
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Newport News, Virginia 23606
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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765 Image Way
Orange City, Florida 32763
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Orlando, Florida 32806
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Port Charlotte, Florida 33980
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Richmond, Virginia 23235
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63129
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10 Barnes West Drive
Saint Louis, Missouri 63141
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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150 Entranceway Drive
Saint Peters, Missouri 63376
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Saint Petersburg, Florida 33705
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Sarasota, Florida 34232
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Seneca, South Carolina 29672
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Smyrna, Tennessee 37167
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Southaven, Mississippi 38671
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Spartanburg, South Carolina 29307
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Spring Hill, Florida 34608
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3402 West Doctor Martin Luther King Junior Boulevard
Tampa, Florida 33607
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4100 Waterman Way
Tavares, Florida 32778
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Tyler, Texas 75702
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Venice, Florida 34285
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Virginia Beach, Virginia 23456
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