A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:3/8/2019
Start Date:April 2, 2014
End Date:October 18, 2020

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A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC)

This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of
veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant
chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.


Inclusion Criteria:

1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy
(excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical
exam or radiologic studies.

2. Documented Breast Cancer Gene (BRCA) germline mutation testing.

3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth
Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.

4. ECOG Performance status of 0 to 1.

5. Women must be determined to be not of childbearing potential (surgically sterile, or
postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR
they must have a negative serum pregnancy test prior to randomization.

Exclusion Criteria:

1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic
therapy radiotherapy or investigational agents) with therapeutic intent for current
breast cancer.

2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a
Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.

3. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal
agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator
(SERM). Subjects must have discontinued use of such agents prior to beginning study
treatment.

4. A history of seizure within 12 months prior to study entry.

5. Pre-existing neuropathy from any cause in excess of Grade 1.
We found this trial at
62
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910 East Houston Street
Tyler, Texas 75702
400
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Tyler, TX
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Allentown, Pennsylvania 18103
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Allentown, PA
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100 Ridgefield Court
Asheville, North Carolina 28806
856
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Asheville, NC
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100 Penn Street
Baltimore, Maryland 21201
1148
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Baltimore, MD
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1609 Hospital Parkway
Bedford, Texas 76022
341
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Bedford, TX
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Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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Chapel Hill, North Carolina 27514
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Charlottesville, Virginia 22908
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Chicago, Illinois 60637
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Chicago, IL
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1740 West Taylor Street
Chicago, Illinois 60612
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Cincinnati, OH
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Cleveland, Ohio 44111
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9500 Euclid Avenue
Cleveland, Ohio 44195
898
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Cleveland, OH
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899
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Cleveland, OH
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Columbus, OH
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Dallas, TX
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345
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Fargo, North Dakota 58102
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Fort Myers, FL
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Fort Worth, TX
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200 Technology Drive
Hooksett, New Hampshire 03106
1427
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Hooksett, NH
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925 Gessner Road
Houston, Texas 77024
565
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Houston, TX
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340 West 10th Street
Indianapolis, Indiana 46202
642
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Indianapolis, IN
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Indianapolis, Indiana 46256
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Indianapolis, IN
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Jacksonville, Florida 32224
1069
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4321 Washington Street
Kansas City, Missouri 64111
196
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1345 Unity Place
Lafayette, Indiana 47905
616
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Lafayette, IN
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Las Vegas, NV
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Los Angeles, California 90033
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600 Highland Avenue
Madison, Wisconsin 53705
574
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Madison, WI
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600
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Maywood, IL
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Miami, FL
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910 East 26th Street
Minneapolis, Minnesota 55404
550
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Minneapolis, MN
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250 25th Avenue North
Nashville, Tennessee 37203
617
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Nashville, TN
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New Brunswick, New Jersey 08903
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New Brunswick, NJ
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1290
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New York, NY
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Newark, DE
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Orlando, Florida 32806
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3705 West 15th Street
Plano, Texas 75075
332
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Plano, TX
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Providence, Rhode Island 02905
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Richmond, Virginia 23219
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5666 East State Street
Rockford, Illinois 61108
560
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Rockford, IL
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Salinas, California 93901
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Salt Lake City, Utah 84112
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7901 Frost Street
San Diego, California 92123
1140
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San Diego, CA
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Sayre, Pennsylvania 18840
1163
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Scottsdale, Arizona 85258
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Scottsdale, Arizona 85259
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1000 East 23rd Street
Sioux Falls, South Dakota 57105
403
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Sioux Falls, SD
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Stanford, California 94305
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Tampa, Florida 33612
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603 North Wilmot Road
Tucson, Arizona 85711
829
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Tweed Heads, New South Wales
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Virginia Beach, Virginia 23456
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West Hollywood, CA
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818 North Emporia Avenue
Wichita, Kansas 67214
26
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Wichita, KS
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Winston-Salem, North Carolina 27103
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Ypsilanti, Michigan 48106
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