Phase II of the trial was presented in 2009 ASCO Plenary Session
THE WOODLANDS, Texas, July 20 /PRNewswire/ -- US Oncology, Inc. today announced that US Oncology Research will participate in the BiPar Sciences' Phase III, Multi-center, Open-Label, Randomized Trial of Gemcitabine/Carboplatin (G/C), with or without BSI-201, in patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and HER2-negative metastatic breast cancer.
Joyce O'Shaughnessy, M.D., co-chair of the US Oncology Breast Cancer Research Committee, associate director for clinical research for US Oncology and co-director of the Breast Cancer Research Program at Baylor-Charles A. Sammons Cancer Center and Texas Oncology, a US Oncology affiliate in Dallas, Texas, will lead the study as a follow-up to the Phase II study presented in a plenary session at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) held May 29-June 2, 2009, in Orlando, Fla.
"We are very pleased to be participating in this clinical trial of BSI-201 which is a very promising new treatment for metastatic triple negative breast cancer," says Dr. O'Shaughnessy. "We expect that accrual will be very rapid within the US Oncology network and hope that this trial will lead to rapid FDA approval of what appears so far to be a well tolerated and effective therapy."
BSI-201 targets PARP, or poly (ADP-ribose) polymerase, a key enzyme involved in DNA repair and cell proliferation. By inhibiting the enzymatic activity of PARP, BSI-201 significantly enhances the anti-tumor effects of chemotherapy and has shown promising safety and efficacy results in patients with solid tumors.
"We are extremely pleased to be launching the Phase 3 clinical trial so rapidly after the close of the Phase 2 trial," said Barry Sherman, M.D., head of clinical development at South San Francisco-based BiPar Sciences, which is developing BSI-201. BiPar is a wholly owned subsidiary of Paris-based sanofi-aventis. "Our primary focus now is enrolling patients in this trial with a similar sense of urgency."
Physicians within the US Oncology network are expected to enroll more than 100 participants in this 420-patient study. Enrollment in the study opened July 17 in centers nationwide.
"The BSI-201 PARP Inhibitor is a potential game changing therapy in the treatment of triple-negative breast cancer. US Oncology Research is excited about the opportunity to continue our development collaboration with BiPar on this important potential new therapy," said Steve Smith, vice president and general manager of Research and Personalized Science for US Oncology Research. "We are eager to leverage the US Oncology Research network to support the study."
Patients targeted for the study include adults with histologically documented breast cancer that is ER-negative, PR-negative, and HER2- non-overexpressing after treatment with gemcitabine/carboplatin with or without BSI-201. Patients must have measurable metastatic breast cancer with zero to two prior chemotherapy regimens for metastatic disease; adjuvant chemotherapy is allowed. Patients interested in learning more about participation should contact Laura Guerra, RN, CCRC, director of Research Clinical Operations and Women's Oncology and Early Phase Research with US Oncology at 281-863-1000 or visit www.usoncology.com.
Primary objectives of the study are to evaluate: overall survival (OS), progression-free survival (PFS), the objective response rate (ORR), and to further evaluate the safety and tolerability of BSI-201 in combination with gemcitabine and carboplatin.
Phase II of the study in triple negative breast cancer patients found that BSI-201 + G/C resulted in a statistically and clinically significant improvement in clinical benefit rate (CBR), median progression-free survival (PFS) and OS, compared with G/C alone. BSI-201 + G/C was well tolerated with adverse events (AEs) consistent with known safety profiles of G/C regimens.
J Clin Oncol 27:18s, 2009 (suppl; abstr 3)
About US Oncology Research
With experienced investigators and dedicated research nurses, US Oncology Research represents the largest research network specializing in Phase I-IV oncology clinical trials in the United States. US Oncology Research serves more than 80 sites in 200 locations with over 70 open trials being managed at any given time.
Additionally, the research network has accrued over 38,500 patients since its inception and contributed to the development of 36 of the latest cancer-fighting drugs approved by the FDA. For more information, visit the US Oncology Research section under About US Oncology on the company's Web site, www.usoncology.com.
About US Oncology
US Oncology, Inc., headquartered in The Woodlands, Texas, works closely with physicians, payers, biotechnology, pharmaceutical and medical equipment manufacturers, to identify and deliver innovative services that enhance patient access to advanced cancer care. US Oncology supports one of the nation's foremost cancer treatment and research networks, accelerating the availability and use of evidence-based medicine and shared best practices.
US Oncology uses its expertise to support every aspect of the cancer care delivery system--from drug development to distribution and outcomes measurement--enabling the company to help increase the efficiency and safety of cancer care. According to the company's last quarterly earnings report, US Oncology is affiliated with 1,227 physicians operating in 468 locations, including 95 radiation oncology facilities in 39 states. For more information, visit the company's Web site, www.usoncology.com.
SOURCE US Oncology, Inc.