Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Metastatic Breast Cancer

In brief

The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.

Key facts

Study ID

NCT01506609

Run by

AbbVie

People needed

294

Starts

2012-01-23

Expected to finish

2020-09-02

Last updated by the study team

2021-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
• Pregnant or breastfeeding.

Where it is running

• Banner MD Anderson Cancer Ctr /ID# 118695 — Gilbert, Arizona, United States
• University of Arkansas for Medical Sciences /ID# 60750 — Little Rock, Arkansas, United States
• Moore UC San Diego Cancer Center /ID# 60754 — La Jolla, California, United States
• The Angeles Clinic and Researc /ID# 60743 — Los Angeles, California, United States
• Stanford University School of Med /ID# 65488 — Stanford, California, United States
• Cedars-Sinai Medical Center - West Hollywood /ID# 60760 — West Hollywood, California, United States
• Univ of Colorado Cancer Center /ID# 60751 — Aurora, Colorado, United States
• Lynn Cancer Institute, Boca /ID# 60749 — Boca Raton, Florida, United States
• Holy Cross Hospital /ID# 62995 — Fort Lauderdale, Florida, United States
• Moffitt Cancer Center /ID# 60746 — Tampa, Florida, United States
• Florida Cancer Specialists - East /ID# 60762 — West Palm Beach, Florida, United States
• University of Illinois - Chicago /ID# 106175 — Chicago, Illinois, United States
• Northwestern University Feinberg School of Medicine /ID# 60755 — Chicago, Illinois, United States
• Rush University Medical Center /ID# 65489 — Chicago, Illinois, United States
• Midwestern Regional CTC /ID# 60744 — Zion, Illinois, United States
• Johns Hopkins University /ID# 60759 — Baltimore, Maryland, United States
• Massachusetts General Hospital /ID# 64582 — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute /ID# 93833 — Boston, Massachusetts, United States
• William Beaumont Hospital /ID# 95417 — Royal Oak, Michigan, United States
• Washington University-School of Medicine /ID# 62724 — St Louis, Missouri, United States
• Beth Israel Medical Center /ID# 87993 — New York, New York, United States
• Memorial Sloan Kettering Cancer Center-Koch Center /ID# 63222 — New York, New York, United States
• Duke University Medical Center /ID# 60747 — Durham, North Carolina, United States
• Penn State University and Milton S. Hershey Medical Center /ID# 62723 — Hershey, Pennsylvania, United States
• University of Alabama at Birmingham - Main /ID# 62994 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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