NCT01251874

Velipariband Carboplatin in Treating Women With HER2-Negative MetastaticBreast Cancer

Study identifier: NCT01251874
Full study details on clinicaltrials.gov

Name of PARP Inhibitor used in study:

Veliparib (Abbott)

Eligibility:

• Patients must have metastatic or locally advanced inoperable breast cancer that fulfills one of the following two criteria:
  • Triple-negative breast cancer
  • ER and/or PR positive, HER2 negative if their tumors have been shown to be deficient for the FA pathway, based on FATSI immunofluorescence screening
• Patients with ER- and/or PR-positive breast cancer will be consented to have their existing, or to be obtained, paraffin-embedded tumor tissue screened for FA deficiency
• Patients with treated brain metastases and life expectancy of greater than 3 months allowed, however, patients with uncontrolled CNS metastasis are not eligible

Type of study:

Randomized, Phase II trial for patients with triple-negative breast cancer

Treatment:

• carboplatin IV over 1 hour on day 1 and oral veliparib twice daily on days 1-7 or 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Study sites:

District of Columbia

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, 20007
Contact: Clinical Trials Office - Lombardi Cancer Center 202-444-0381       

New York

New York Cancer Consortium      Recruiting
Bronx, New York, United States, 10461
Contact: Joseph A. Sparano, MD     718-904-2555     jsparano@montefiore.org   

Ohio

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State
University Comprehensive Cancer Center
Columbus, Ohio,  43210-1240
Contact Study Coordinator: Jullie Nutter: julie.nutter@osumc.edu

or call Ohio State University Cancer Clinical Trial Matching Service:  866-627-7616   

Page updated 03/26/11

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