RxTrials Institute Drug Pipeline Alert

Women who took Novartis’ Femara after completing five years of tamoxifen therapy reduced their risk of breast cancer recurrence by 63 percent compared with those who had not received the drug, according to an analysis of a Phase III trial.

The international, double-blind, randomized, multicenter MA-17 trial, which was conducted by the National Cancer Institute of Canada Clinical Trials Group, evaluated a subset of women in the original placebo arm, Novartis said.

The trial, which was unblinded in 2003 after the first planned interim analysis, showed Femara (letrozole) helped reduce the risk of breast cancer recurrence. Women in the placebo arm were given the chance to start treatment with the drug.

The analysis, which supports the benefit of beginning Femara therapy within three months of completing tamoxifen, was published in the Journal of Clinical Oncology.