'We plan to share these data with the FDA to discuss the possibility of filing a supplemental Biologics License Application for Avastin plus chemotherapy in first-line metastatic breast cancer.'

"This study is very important for two reasons: It demonstrates that Avastin has clinical benefit when used in combination with chemotherapy in first-line metastatic breast cancer and reinforces our belief that targeting angiogenesis can result in patient benefit in multiple tumor types, including colorectal and non-small cell lung cancers," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer.

"We are particularly excited about the results in this first-line study since they occurred at an early interim analysis," he added.

Next Step: FDA

The National Cancer Institute (NCI), part of the National Institutes of Health, sponsored the trial under a Cooperative Research and Development Agreement between NCI and Genentech. A network of researchers led by the Eastern Cooperative Oncology Group (ECOG) conducted the research. Detailed results will be presented at an upcoming medical meeting, according to the manufacturers.

"We plan to share these data with the FDA to discuss the possibility of filing a supplemental Biologics License Application for Avastin plus chemotherapy in first-line metastatic breast cancer," said Dr. Barron. "We would like to acknowledge ECOG and NCI for their work on this study, as well as the patients and their families who participated in the trial, for their important role in identifying a potential new treatment option for women with breast cancer."

Trial Participants

This Phase III study was a randomized, controlled, multicenter trial that enrolled 722 women with previously untreated metastatic breast cancer, said the companies.

The patients enrolled in this trial were randomized to receive treatment with paclitaxel with or without Avastin. Patients with HER2-positive metastatic breast cancer were not enrolled in the study unless they had received prior treatment with Herceptin (Trastuzumab) or were unable to receive treatment with Herceptin.

Patients who had received adjuvant paclitaxel within the previous 12 months and patients with a prior history of blood clots or who were receiving blood thinners also were excluded from the study.

Adverse Events

The safety assessment for this trial currently is being reviewed, but thus far no new signals have been observed, accoring to the interim analysis. More detailed information about adverse events will be available when ECOG presents the full data set at an upcoming medical meeting.

Adverse events in this study appeared to be similar to those observed in previous clinical trials with Avastin in combination with chemotherapy in metastatic breast cancer.

Adverse events that occurred more often in the Avastin arm included neuropathy, hypertension and proteinuria. Serious bleeding and blood clots were rare in this study. Additional adverse events were similar in both treatment arms.