Phase 3 study of Avastin for early stage breast cancer enrollment suspended

Roche announced the suspension of enrollment by the National Cancer Institute and US Eastern Cooperative Oncology Group (ECOG) for a Phase 3 study of Avastin (bevacizumab, from Roche and Genentech) in combination with chemotherapy in women with early-stage breast cancer. This decision was based on a pre-planned cardio-toxicity analysis of the first 200 patients enrolled. The protocol for the trial specifies that enrollment be suspended if six or more cases of clinical congestive heart failure (CHF) are seen in the first 200 patients and this threshold was met. All six of the patients received Avastin in combination with anthracycline chemotherapy.  There have been no deaths due to cardiac toxicity.

Avastin is indicated for metastatic colorectal carcinoma, in combination with 5-FU-based chemotherapy; first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel; metastatic HER2-negative breast cancer in chemotherapy-naive patients, in combination with paclitaxel; glioblastoma, as a single agent for patients with progressive disease following prior therapy; and metastatic renal cell carcinoma (mRCC) in combination with interferon alfa.

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