Second Line Breast Cancer Trial

Phase 3

Completed

• Conditions: Advanced Breast Cancer
• Interventions: Drug: Fulvestrant; Drug: Anastrozole

• Registration Number: NCT00635713
• Lead Sponsor: AstraZeneca

Brief Summary

The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-05
• Study Completion: 2004-09
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-13
• Study First Posted: 2008-03-14
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-09
• Last Update Posted: 2009-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 588

Inclusion Criteria

• postmenopausal women with confirmation of breast cancer
• objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer

Exclusion Criteria

• presence of life-threatening metastatic visceral disease
• previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
• more than 1 prior endocrine medical treatment for advanced breast cancer .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fulvestrant	Faslodex 125mg and Arimidex 1 mg
1	Anastrozole	Faslodex 125mg and Arimidex 1 mg
2	Anastrozole	Faslodex 250mg and Arimidex 1mg
2	Fulvestrant	Faslodex 250mg and Arimidex 1mg

Primary Outcome Measures

Name	Time	Method
time to tumor progression	Every 3 months

Secondary Outcome Measures

Name	Time	Method
objective tumor response	Every 3 months
time to treatment failure	Every 3 months
time to death	Every 3 months