Roche announced that enrollment in a phase III clinical trial testing bevacizumab (Avastin) plus chemotherapy for women with early-stage breast cancer was suspended after six patients who were given the drug developed congestive heart failure. Study protocols required that enrollment be stopped if six or more cases of congestive heart failure occurred in the first 200 patients, according to the company.
The E5103 trial, led by the National Cancer Institute and the U.S. Eastern Oncology Group, was started in November 2007 and had enrolled 3,439 patients out of a planned 4,950 patients. The study was designed to compare doxorubicin/cyclophosphamide (AC) followed by paclitaxel; AC/bevacizumab followed by paclitaxel/bevacizumab; and AC/bevacizumab followed by paclitaxel/bevacizumab followed by bevacizumab × 10.
The trial’s independent data safety monitoring board will assess the data and recommend the next steps in consultation with NCI and ECOG, according to a Roche statement.
The company said the rate of congestive heart failure in the trial was consistent with that previously observed with bevacizumab.
Five of the six cases have been resolved, with the sixth occurring at the end of the protocol. None of the patients enrolled in the study died due to cardiac problems, Roche said in its statement.