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Phase III CONFIRM Study Shows FASLODEX(R) (fulvestrant) Injection 500 mg May Delay Time of Disease Progression Over 250-mg Dose in Postmenopausal Women With Hormone Receptor-Positive Advanced Breast Cancer
Date:12/10/2009

WILMINGTON, Del., Dec. 10 /PRNewswire-FirstCall/ -- 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, p=0.006) when compared with fulvestrant 250 mg, the dose currently approved by the Food and Drug Administration (FDA). CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer) a double-blind, double-dummy study, evaluated the efficacy of fulvestrant 500 mg/month (n=362) compared with fulvestrant 250 mg/month (n=374) to treat postmenopausal women with hormone receptor-positive metastatic breast cancer who have progressed or recurred following prior endocrine therapy.(i)

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"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 measu
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