3 Years of Anastrozole vs. no Treatment as Extended Adjuvant Therapy for Postmenopausal Women With Breast Cancer

Phase 3

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT00300508
• Lead Sponsor: AstraZeneca

Brief Summary

The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-01
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-09
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-30
• Last Update Posted: 2009-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 856

Inclusion Criteria

• No disease recurrence at time of randomization,
• patients with breast cancer after surgery,
• 5 years (+/- 12 months) of prior endocrine therapy

Exclusion Criteria

• Premenopausal patients,
• unknown or negative receptor status,
• Secondary malignant tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence-free and overall survival

Secondary Outcome Measures

Name	Time	Method
Secondary cancers

Trial Locations

Locations (2)

Research site; 🇦🇹 Hollabrunn, Austria

Research Site; 🇦🇹 Zams, Austria