Spots Global Cancer Trial Database for Efficacy and Safety of 500mg of Fulvestrant

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Trial Identification

Brief Title: Efficacy and Safety of 500mg of Fulvestrant

Official Title: A Phase II Multi-Center Study to Evaluate the Efficacy and Safety of 500mg of Fulvestrant (Faslodex) as a First Line Hormonal Treatment in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer

Study ID: NCT00585507

Conditions

Breast Cancer

Interventions

Fulvestrant

Study Description

Brief Summary: Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness. In this study, a higher dose will be used to see whether an improved outcome will result.

Detailed Description: * Fulvestrant will be administered by intramuscular injection on day 1, day 15 and day 29 and then every 28 days thereafter. * Participants will have a physical examination and blood work performed on each treatment date. After teh study treatment has been completed, the physical examinations will be done every three months for the first 2 years, every 6 months for years 2-5, and annually after 5 years. * Participants may remain on study treatment until disease progression or until they experience serious side effects.