ATAC - Quality of Life Sub-Protocol

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Anastrozole; Tamoxifen

Criteria

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