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Beaumont, U-M Open Study of Drug for Advanced Breast Cancer
Date:10/28/2009

receptors is found, making the existing treatments that target these receptors in other patients ineffective for TNBC patients. No treatment has been approved specifically for TNBC.

TNBC patients tend to be pre-menopausal; a large subgroup is African American. Many women with this cancer also have a BRCA-1 or BRCA-2 genetic mutation. TNBC is a fast-growing form of cancer with a higher risk of recurrence than other forms of breast cancer; average survival after recurrence is nine months.

"Based on recently reported clinical trials, the PARP inhibitors, including BSI-201, appear to be very beneficial and cause few side effects in patients with metastatic TNBC," says N. Lynn Henry, M.D., Ph.D., medical oncologist in the U-M Breast Oncology Program and principal investigator for this study at the University of Michigan. "It is exciting to be able to provide this new experimental treatment for our patients."

BSI 201 is seen as a significant breakthrough in the treatment of this aggressive cancer. A phase II study of the drug, reported at the May 2009 American Society of Clinical Oncologists annual meeting, found 62 percent of 116 patients who received the study drug with chemotherapy experienced a clinical benefit, compared to 22 percent who received only chemotherapy. Tumors shrank in 48 percent of women tested with BSI 201, compared with 16 percent on chemotherapy alone. The study found that the time till the cancer progressed for participants who received BSI 201 was a median of 6.9 months, compared to 3.3 months for women who received chemotherapy alone. Overall survival was 9.2 months with BSI 201 compared with 5.7 months for chemotherapy alone.
TNBC patients who may qualify for the study should call:

Beaumont Hospital, Cancer Clinical Trials at Royal Oak, 248-551-7695; Cancer Clin
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