A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:2/17/2019
Start Date:August 5, 2014
End Date:April 28, 2020

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A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination
with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced,
unresectable, BRCA-associated breast cancer.


Inclusion Criteria:

1. Histologically or cytologically confirmed breast cancer that is either locally
advanced or metastatic. Locally advanced breast cancer must not be amenable to
surgical resection or radiation with curative intent.

2. Suspected deleterious or deleterious BRCA1 and/or BRCA2 germline mutation.

3. Breast cancer must be HER2-negative.

4. Measurable or non-measurable (but radiologically evaluable) disease per Response
Evaluation Criteria In Solid Tumors (RECIST), version 1.1 on computed tomography (CT)
scan (within 28 days of randomization) with at least one lesion outside previously
irradiated areas.

5. ECOG Performance status of 0 to 2.

6. Adequate hematologic, renal, and hepatic function (within 28 days of randomization).

Exclusion Criteria:

1. More than two prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin,
capecitabine) for metastatic disease.

- Regimens received in the adjuvant/neoadjuvant setting or for locally advanced
breast cancer within the past 6 months will also be considered toward the maximum
of 2 prior lines of therapy. Adjuvant/neoadjuvant chemotherapy for one cancer
event will count as one prior line of therapy, if received within the past 6
months.

- Previous treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and
signal transduction agents (e.g., erlotinib, gefitinib, everolimus, bevacizumab)
are allowed and are not counted towards the prior line of therapy.

2. Progressed or recurred within 12 months of completing platinum therapy or received > 1
prior line of platinum therapy for breast cancer in any setting (adjuvant or
neoadjuvant).

3. Prior therapy with PARP inhibitors.

4. Prior taxane therapy administered for the treatment of metastatic breast cancer with
the below exceptions.

- Prior taxane therapy for metastatic breast cancer is allowed if the patient
received ≤ 1 full cycle (i.e., therapy discontinued within 4 weeks for subjects
receiving weekly paclitaxel or Abraxane; therapy discontinued within 3 weeks for
subjects receiving paclitaxel or docetaxel every 3 weeks) in the absence of
progression or if taxane therapy for metastatic disease was > 12 months prior to
C1D-2.

- Use of taxanes as adjuvant therapy or to treat locally advanced disease is
permitted, if given more than 6 months prior to C1D-2

5. Known history of allergic reaction to cremophor-paclitaxel, carboplatin, Azo-Colourant
Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also
known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.

6. Active CNS metastases or leptomeningeal disease.
We found this trial at
42
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Denver, Colorado 80218
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Albuquerque, New Mexico 87102
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616 Matlock Centre Circle
Arlington, Texas 76012
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21 Hospital Drive
Asheville, North Carolina 28801
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Atlanta, Georgia 30322
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Baltimore, Maryland 21287
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Berazategui, Buenos Aires,
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Boca Raton, Florida 33486
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1740 West Taylor Street
Chicago, Illinois 60612
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Detroit, Michigan 48202
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Duarte, California 91010
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2301 Erwin Road
Durham, North Carolina 27701
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Durham, NC
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1300 Michigan Street Northeast
Grand Rapids, Michigan 49503
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500 University Drive
Hershey, Pennsylvania 17033
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Houston, Texas 77030
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4321 Washington Street
Kansas City, Missouri 64111
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La Jolla, California 92037
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4004 Pioneer Woods Drive
Lincoln, Nebraska 68506
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309 West 23rd Street
New York, New York 10011
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New York, New York 10025
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Newport Beach, California 92663
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34 Maple St
Norwalk, Connecticut 06856
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Pittsburgh, Pennsylvania 15260
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Royal Oak, Michigan 48073
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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Santa Ana, CA
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Seattle, Washington 98104
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1221 Madison Street
Seattle, Washington 98104
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1221 Madison Street
Seattle, Washington 98104
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1221 Madison Street
Seattle, Washington 98104
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Springfield, Massachusetts 01199
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1624 South I Street
Tacoma, Washington 98405
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Tampa, Florida 33612
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3000 Arlington Avenue
Toledo, Ohio 43614
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West Palm Beach, Florida 33401
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Whittier, California 90603
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55 Lake Avenue North
Worcester, Massachusetts 01655
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