Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:December 2013
End Date:March 2020

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A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF EFFICACY AND SAFETY OF ENZALUTAMIDE IN COMBINATION WITH EXEMESTANE IN PATIENTS WITH ADVANCED BREAST CANCER THAT IS ESTROGEN OR PROGESTERONE RECEPTOR-POSITIVE AND HER2-NORMAL

The purpose of this study is to determine if enzalutamide given in combination with
exemestane is safe and effective in patients with advanced breast cancer.

This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of
Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced
Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2-Normal.

Inclusion Criteria:

- Willing and able to provide informed consent;

- Postmenopausal;

- Advanced histologically confirmed breast cancer that is ER+, PgR+, or both, and HER-2
normal;

- Up to one prior hormone therapy and up to one prior chemotherapy in the advanced
setting is allowed;

- Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen
that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block
or unstained serial slides accompanied bay an associated pathology report;

- Measurable disease. Patients with non-measurable bone or skin disease as their only
manifestation of advanced breast cancer are also eligible;

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

Exclusion Criteria:

- Any severe concurrent disease, infection, or comorbid condition that renders the
patient inappropriate for enrollment in the opinion of the investigator;

- 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, in the opinion of the investigator;

- Current or previously treated brain metastasis or leptomeningeal disease;

- Prior therapy (> 28 days) with exemestane in the metastatic setting (Patients
receiving exemestane in the adjuvant setting and having disease recurrence more than 1
year after treatment discontinuation are eligible);

- Requires treatment for tuberculosis or HIV infection;

- Radiation therapy within 7 days before randomization;

- History of another invasive cancer within 5 years before randomization;

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

- Clinically significant cardiovascular disease;

- Active gastrointestinal disorder;

- Major surgery within 28 days prior to randomization;

- Treatment with any oral anticancer or with any non-hormonal anticancer agent within 14
days before randomization;

- Treatment with any approved or investigational agent that blocks androgen synthesis or
targets the androgen receptor;

- Treatments with any of the following medications within 14 days before randomization:
Estrogens, Androgens, or Systemic radionuclides;

- Hypersensitivity reaction to exemestane.
We found this trial at
76
sites
Fort Worth, Texas 76177
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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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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12605 East 16th Avenue
Aurora, Colorado 80045
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13001 E. 17th Pl.
Aurora, Colorado 80045
303-724-5000
University of Colorado Cancer Center - Anschutz Cancer Pavilion The University of Colorado Denver |...
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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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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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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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UZA
10 Wilrijkstraat
Edegem, Antwerpen 2650
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Englewood, Florida 34223
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Fairfield, Ohio 45014
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Fort Worth, Texas 76177
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Fort Worth, Texas 76177
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Gainesville, Florida
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Greenville, South Carolina 29615
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Houston, Texas 77024
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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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Lone Tree, Colorado 80124
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Mechanicsville, Virginia
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Midlothian, Virginia
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800 East 28th Street
Minneapolis, Minnesota 55407
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Minneapolis, Minnesota 55405
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910 East 26th Street
Minneapolis, Minnesota 55407
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Morristown, New Jersey 07960
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Naples, Florida 34102
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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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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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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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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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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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Saint Louis, Missouri 63129
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10 Barnes West Drive
Saint Louis, Missouri 63141
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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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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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