Official Title: “A Randomised, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer”

The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: fulvestrant
  • 500 mg intramuscular injection
• Drug: anastrozole
  • 1 mg oral tablet

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Anastrozole
• Experimental: 2
  • Fulvestrant + Anastrozole

Primary Measures

• Clinical benefit rate
  • Time Frame: analysed when all patients have been in the study for 6 months
    Safety Issue?: No

Secondary Measures

• Objective response, time to progression, duration of response, duration of clinical benefit and safety
  • Time Frame: analysed when all patients have been in the study for 6 months
    Safety Issue?: Yes
• Response to subsequent therapy and tumour marker levels
  • Time Frame: analyzed after 6 months
    Safety Issue?: No

Inclusion Criteria:

• Confirmed hormone receptor positive advanced breast cancer, postmenopausal women

Exclusion Criteria:

• Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Faslodex Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00274469

Study ID Number: D6995C00006

ClinicalTrials.gov Identifier: NCT00274469

Health Authority: United States: Food and Drug Administration