Breast Cancer Trial suspended

CANCER.GOV - An NCI-sponsored phase III clinical trial for women with high-risk breast cancer has temporarily suspended their trial while researchers study the incidence of congestive heart failure among participants.

The E5103 trial is comparing bevacizumab (Avastin) combined with standard adjuvant chemotherapy versus adjuvant chemotherapy alone for women with lymph node-positive or high-risk lymph node-negative breast cancer who have undergone lumpectomy or mastectomy.

As a preplanned safety measure, the investigators suspended accrual after 6 of the first 200 women enrolled in the trial developed clinical congestive heart failure.

In the cases where follow-up data were available, the symptoms of congestive heart failure resolved with treatment. More than 3,300 women are currently participating in the study.

NCI and the Eastern Cooperative Oncology Group suspended recruitment of new patients on September 24. Women currently participating in the trial will be notified of these adverse events and may choose to continue receiving their assigned treatment or withdraw from the study.