Results In 'The New England Journal Of Medicine' Confirm Novartis Drug Femara(R) Is Superior To Tamoxifen After Breast Canc...(n early significant reduction in distant...),Health

"Femara is the only aromatase inhibitor to demonstrate consistent, early and significant reduction in risk of distant metastases," said Alessandro Riva, MD, Global Head Oncology Development, Novartis Oncology. "Based on these results, starting with Femara monotherapy for five years in the adjuvant setting instead of tamoxifen may offer breast cancer patients the opportunity for a better outcome."

Study details

This Phase III, randomized, double-blind, controlled clinical trial enrolled more than 8,000 postmenopausal women with early breast cancer in 27 countries[2].

Patients were randomly assigned one of four treatment regimens: (1) five years of tamoxifen only; (2) five years of Femara only; (3) two years of tamoxifen followed by three years of Femara; (4) two years of Femara followed by three years of tamoxifen.

The primary endpoint of the study was disease-free survival, defined as the time from randomization to the first of any of the following events: recurrence at local, regional, or distant sites; a new invasive cancer in the contralateral breast; any second, non-breast cancer; or death without a previous cancer event. Other endpoints included time to breast cancer recurrence, time to distant breast cancer recurrence and overall survival.

In 2005, following initial results showing superiority of Femara monotherapy over tamoxifen monotherapy in improving disease-free survival and reducing the risk of recurrence, the tamoxifen-only treatment arm was unblinded and approximately one quarter of those patients selectively crossed over to Femara treatment. The other three treatment arms remained blinded. Subsequent analyses were designed to estimate the extent to which the crossover affected the comparative benefit of Femara.