A higher dose of fulvestrant is well tolerated and more active than the standard, lower dose in postmenopausal patients with advanced breast cancer.

"We believe that, based on the results of this study, treatment and practice should change; patients should receive the 500 mg dose," said Angelo Di Leo, M.D., Ph.D., director of the Department of Oncology at the Hospital of Prato, Italy.

Fulvestrant, sold under the trade name Faslodex by AstraZeneca, is an oestrogen receptor antagonist used for the treatment of metastatic receptor-positive breast cancer in women who have progressed or had recurrent cancer after prior endocrine therapy.

Di Leo and colleagues conducted the CONFIRM study - Comparison of Faslodex In Recurrent or Metastatic breast cancer - to compare the efficacy, response rate, clinical benefit, duration of benefit and response, quality of life and overall survival of the drug at the standard 250 mg per month dose and 500 mg per month dose. Over a two-year period, the researchers recruited 736 women from 128 centres located in 17 countries to participate in this study.

Findings showed that the 500 mg dose of fulvestrant was more active and as well tolerated as the 250 mg dose of fulvestrant, according to Di Leo, who presented results of this randomized, phase III trial at the CTRC-AACR Annual San Antonio Breast Cancer Symposium, held Dec. 9-13, 2009.

The researchers are currently conducting the Trans-CONFIRM study in an effort to understand if the higher dose is mandatory in all patients, or only some.