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Vered Stearns, M.D. Associate Professor of Oncology Co-Director, Breast Cancer Program Breast Cancer Research Chair in Oncology Breast Cancer Program 1650 Orleans Street CRB I, Room 144 Baltimore, MD 21231-1000 Phone: 443-287-6489 Fax: 410-614-4073 E-mail: [email protected] RE: A Phase II Study of the PARP Inhibitor, Iniparib (BSI-201), in Combination with Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis (NA_00036553, SKCCC J1081, TBCRC 018) Dear Fellow Physician, It is our pleasure to send a brief update of our phase II research study evaluating the efficacy of Iniparib (BSI-201, Sanofi-Aventis/BiPAR Sciences), plus irinotecan chemotherapy to treat women with progressive triple negative breast cancer brain metastases. Below are some high points: • Eligibility includes two groups: (1) patients with progressive brain metastases after radiation therapy, or (2) patients who are radiation therapy-naive and asymptomatic. • Treatment includes irinotecan on days 1 and 8 of a 21 day cycle, with iniparib on days 1, 4, 8 and 11. All study-based therapy will be administered intravenously. • Monitoring for intracranial and extracranial response will occur every 9 weeks with a brain MRI and a CT of chest/abdomen and pelvis. This trial is being open through the Translational Breast Cancer Research Consortium and includes several sites across the country. Please see more information here: http://clinicaltrials.gov/ct2/show/NCT01173497?term=iniparib+and+irinotecan&rank=2 We would welcome referrals of your patients with triple negative breast cancer brain metastases. For more information or to discuss eligibility questions, please email [email protected]. Sincerely, Vered Stearns, M.D. Principal Investigator: Vered Stearns, M.D. Protocol Number: NA_00036553 Approved December 20, 2011