Everolimus Trial Stopped for Benefit in Breast Cancer - in Oncology/Hematology, Breast Cancer from MedPage Today

Medical News: Everolimus Trial Stopped for Benefit in Breast Cancer - in Oncology/Hematology, Breast Cancer from MedPage Today

Excerpt:

"A phase III trial of everolimus (Afinitor) in locally advanced or metastatic breast cancer has been halted after an interim analysis indicated that the study's primary endpoint -- a significant difference in progression-free survival relative to a control therapy after six weeks -- was met, the drug's manufacturer said.

According to Novartis, the combination of everolimus and exemestane (Aromasin) was more effective than the latter drug and placebo in preventing tumor growth in women with estrogen receptor-positive, HER2-negative breast cancer that did not respond to other aromatase inhibitors.

The international trial, BOLERO-2, was testing everolimus at 10 mg/day orally plus 25 mg/day of oral exemestane. It included more than 700 patients randomized 2:1 to the combination versus the control regimen.

Novartis did not indicate the degree of improvement in progression-free survival with the combination. It promised that full results would be presented at "an upcoming medical conference" and that it would file marketing applications worldwide by the end of this year."