Pilot Study Opens the Door for Avastin Use in Curative Setting for Women With Bre... (nts each. This is within the range expec...)

Pilot Study Opens the Door for Avastin Use in Curative Setting for Women With Breast Cancer

Date:12/17/2007

nts each. This is within the range expected to occur with the use of anthracycline based chemotherapy alone.

Following the completion of the accrual of Avastin adjuvant colon cancer trials and now confirmation of the safety of Avastin in the adjuvant breast cancer setting, the phase III adjuvant breast cancer programme is already recruiting patients. The large adjuvant programme consists of 2 trials in HER- 2 negative breast cancer patients:

-- The E5103 study is set to include 4,950 patients and will compare

Avastin with the addition of an anthracycline-containing chemotherapy

course versus anthracycline-containing chemotherapy alone.

-- The BEATRICE study will investigate Avastin in combination with

standard chemotherapies compared to chemotherapies alone in 2,530

planned patients who are not candidates for hormonal therapy.

In addition, Avastin is being investigated in HER-2 positive breast cancer patients post surgery via the BETH trial. This study will investigate the

addition of Avastin to Herceptin (trastuzumab) in combination with established chemotherapy regimen.

Worldwide, breast cancer is the leading cause of cancer death in women under the age of 55. Each year there are more than one million diagnoses and more than 400,000 deaths from breast cancer (2).

About E2104

E2104 is a phase II study designed to evaluate the safety and feasibility of incorporating Avastin into an anthracycline containing adjuvant therapy regimen. The study included 226 women with lymph node positive breast cancer who have had already undergone surgical removal (mastectomy) of the lesion and lymph node dissection. The study was sponsored by the National Cancer Institute (NCI), part of the US National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). Patients were sequentially assigned to
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