Faslodex Advanced Breast Cancer Local Chinese Study

Phase 3

Completed

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

• Registration Number: NCT00327769
• Lead Sponsor: AstraZeneca

Brief Summary

This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-05-18
• Study First Submitted QC: 2006-05-18
• Study First Posted: 2006-05-19
• Study Completion: 2007-09
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 234

Inclusion Criteria

• Postmenopausal advanced breast cancer with oestrogen receptor positive
• Progression under first-line anti-oestrogen therapy.

Exclusion Criteria

• Life-threatening metastasis; contraindication to anastrozole
• >2 regimens of hormonotherapy for advanced breast cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Anastrozole	Anastrozole + Fulvestrant
1	Anastrozole	Anastrozole
2	Fulvestrant	Anastrozole + Fulvestrant

Primary Outcome Measures

Name	Time	Method
Time to Disease Progression (TTP)

Secondary Outcome Measures

Name	Time	Method
Safety & Tolerability.
Clinical Benefit Rate (CBR)
Objective Response Rate (ORR)
Time to Treatment Failure (TTF)

Trial Locations

Locations (1)

Research Site; 🇨🇳 Xi AN, China