The Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide or In Combination With Carboplatin and Paclitaxel Versus Placebo in Subjects With BRCA1 and BRCA2 Mutation and Metastatic Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:10/26/2018
Start Date:January 23, 2012
End Date:May 30, 2019

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A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide
or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally
recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast
cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.

Subjects will be randomized in a 1:1:1 ratio to one of the three treatment groups. The safety
of each treatment group will be assessed by evaluating study drug exposure, adverse events,
serious adverse events, all deaths, changes in laboratory determinations, and vital sign
parameters. The Clinical Benefit Rate (CBR) and Objective Response Rate (ORR) as well as
Progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST)
1.1 will be assessed. Study visits will be conducted according to the protocol schedule and
randomization group. Study visits will include physical examination, laboratory blood sample
collection, and assessment of vital signs, medical history and urinalysis. 12-lead
Electrocardiogram (ECG) will be performed at protocol specified visits.

Inclusion Criteria:

- Histologically or cytologically confirmed breast cancer that is either locally
recurrent or metastatic.

- Locally recurrent disease must not be amenable to surgical resection or radiation with
curative intent.

- Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline
mutation.

- If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received
and progressed on at least one prior standard HER2 directed therapy or the subject
must be ineligible to receive anti-HER2 therapy.

- Measurable or non-measurable (but radiologically evaluable) disease by RECIST
(Response Evaluation Criteria in Solid Tumors) criteria 1.1.

- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.

- Subject must have adequate bone marrow, renal and hepatic function.

- Subject must not be pregnant or plan to conceive a child.

Exclusion Criteria:

- Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1,
or radiotherapy within 28 days prior Cycle 1 Day 1

- More than 2 prior lines of cytotoxic chemotherapy

- Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP
ribose) Polymerase (PARP) inhibitor.

- Prior taxane therapy for metastatic breast cancer.

- A history of or evidence of brain metastases or leptomeningeal disease.

- A history of uncontrolled seizure disorder

- Pre-existing neuropathy from any cause in excess of Grade 1

- Known history of allergic reaction to cremophor/paclitaxel

- Clinical significant uncontrolled conditions â€" active infection, myocardial
infarction, stroke, or transient ischemic attack, psychiatric illness/social
situations that would limit compliance.

- Pregnant or breastfeeding
We found this trial at
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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Baltimore, Maryland 21287
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Berazategui, Buenos Aires,
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Beverly Hills, California 90211
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Birmingham, Alabama 35233
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Boca Raton, Florida 33486
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Boston, Massachusetts 02114
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Boston, Massachusetts 02215
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Charleston, South Carolina 29425
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Chicago, Illinois 60607
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303 East Superior Street
Chicago, Illinois 60611
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1653 West Congress Parkway
Chicago, Illinois 60612
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Durham, North Carolina 27710
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
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2946 East Banner Gateway Drive
Gilbert, Arizona 85234
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500 University Drive
Hershey, Pennsylvania 17033
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6565 Fannin Street
Houston, Texas 77030
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9500 Gilman Dr
La Jolla, California 92093
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4301 West Markham Street
Little Rock, Arkansas 72205
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Los Angeles, California 90025
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Los Angeles, California 90025
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8700 Beverly Blvd
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Memphis, Tennessee 38120
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Memphis, Tennessee 38120
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Memphis, Tennessee 38120
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10 Nathan D Perlman Place
New York, New York 10003
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15260
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Pittsburgh, Pennsylvania 15260
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Royal Oak, Michigan 48073
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Stanford, California 94305
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West Palm Beach, Florida 33401
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Zion, Illinois 60099
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