ATAC - Quality of Life Sub-Protocol

Phase 3

Completed

• Conditions: Quality of Life
• Interventions: Drug: Anastrozole; Drug: Tamoxifen

• Registration Number: NCT00784680
• Lead Sponsor: AstraZeneca

Brief Summary

To compare Quality of Life between the ARIMIDEX group, the NOLVADEX group and the ARIMIDEX plus NOLVADEX combination group during the first two years of treatment. (a) To compare the difference in Quality of Life between the ARIMIDEX group and the NOLVADEX group (b) To compare Quality of Life in the ARIMIDEX plus NOLVADEX combination group with the NOLVADEX group for non-inferiority; if non inferiority is concluded, the difference in QOL between these two groups will be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-04
• Study Completion: 2004-04
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-04
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-30
• Last Update Posted: 2009-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 308

Inclusion Criteria

• Eligible for entry into the main ATAC trial 1033IL/0029
• Completion of a baseline questionnaire

Exclusion Criteria

• Excluded from entry into the main ATAC trial (1033IL/0029)
• If, in the investigators opinion, the patient would be unable to comply with this sub-protocol due to psychiatric or literacy reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Anastrozole	Arimidex 1mg + Nolvadex placebo
2	Anastrozole	Arimidex placebo + Nolvadex 20mg
2	Tamoxifen	Arimidex placebo + Nolvadex 20mg
3	Tamoxifen	Arimidex 1mg + Nolvadex 20mg

Primary Outcome Measures

Name	Time	Method
Time to withdrawal
Time to recurrence