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Pilot Study Opens the Door for Avastin Use in Curative Setting for Women With Breast Cancer
Date:12/17/2007

Roche in collaboration with Genentech commit to large phase III adjuvant

clinical programme set to unlock Avastin's potential in early breast

SAN ANTONIO, Dec. 17 /PRNewswire/ -- According to new phase II study data, Avastin (bevacizumab) can proceed to be tested after breast cancer surgery in combination with anthracycline containing regimens. These findings pave the way for Avastin's use as a curative treatment for women with this devastating disease. Data presented today at the San Antonio Breast Cancer Symposium (SABCS) from the E2104 study showed that standard anthracycline-based chemotherapy (doxorubicin) can be added to Avastin after surgical removal of the breast tumour, without a concerning increase in the incidence of cardiac adverse events typically associated with this form of chemotherapy.

These data support the commencement of phase III adjuvant breast cancer clinical programme which will include over 10,000 patients with early stage breast cancer. Avastin already offers women with late-stage (metastatic) breast cancer the chance to live twice as long without their disease progressing (1).

"The unique way Avastin works also lends itself for use in women with earlier stages of breast cancer" said Dr Kathy Miller of Indiana University School of Medicine, USA and principal investigator of the E2104 study. "We now know that Avastin use in combination with anthracyclines does not result in concerning rates of cardiac dysfunction in the adjuvant setting and armed with this evidence Avastin's impact can be fully validated in a large worldwide phase III clinical trial programme."

Data from the E2104 study have shown that cardiac dysfunction is not a major concern with the treatment combination of Avastin and doxorubicin. As presented in SABCS, two patients with symptomatic congestive heart failure were reported in each of the 2 Avastin-containing treatment arms which included more than 100 patie
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