Fulvestrant 500 mg reduces risk of disease progression in women with metastatic breast cancer

Dec 11 2009

AstraZeneca (NYSE: AZN) today announced that data from a Phase III study of postmenopausal women with hormone receptor-positive advanced breast cancer presented at the San Antonio Breast Cancer Symposium (Abstract 25) showed treatment with fulvestrant (FASLODEX) 500 mg reduced the risk of disease progression (assessed as time to progression (TTP)) by 20% (HR 0.80; 95% CI 0.68-0.94,> a double-blind, double-dummy study, evaluated the efficacy of fulvestrant 500 mg/month>

"Findings from CONFIRM provide additional data showing that increasing the dose of fulvestrant from 250 mg to 500 mg may improve the effectiveness of a currently available treatment option to help maintain disease control longer -- a primary objective of treatment for women with metastatic breast cancer," said Dr. Angelo Di Leo, M.D., Ph.D, Head of Sandro Pitigliani Medical Oncology Unit, Hospital of Prato, Italy, and CONFIRM principal investigator.

Patients were randomized to receive either fulvestrant 500 mg (2 x 250 mg intramuscular injections) or fulvestrant 250 mg/month on days 0, 14 and 28, followed by 500 mg every 28 days thereafter. The primary objective was to compare the efficacy, as measured by TTP, of fulvestrant 500 mg with the approved 250-mg regimen. Secondary objectives included: objective response rate, clinical benefit rate (complete or partial response or stable disease lasting greater than or equal to 24 weeks), duration of clinical benefit, overall survival and quality of life. Safety and tolerability were also assessed.

The CONFIRM Study showed fulvestrant 500 mg significantly prolonged time to progression compared to fulvestrant 250 mg, with a median TTP of 6.5 months at 500 mg dose vs. a median TTP of 5.5 months with 250 mg dose (HR 0.80;>