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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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