NCT00065325

The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer

A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 694 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 32 Years – 91 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Conditions

• Locally Advanced Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Fulvestrant	intramuscular injection
DRUG	Exemestane	oral capsule

Timeline

• Start date: 2003-08-01
• Primary completion: 2006-06-01
• Completion: 2014-09-01
• First posted: 2003-07-23
• Last updated: 2015-02-24

Locations

117 sites across 15 countries: United States, Argentina, Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, Israel, Russia, South Africa, Spain, Sweden, United Kingdom