ATAC - Quality of Life Sub-Protocol

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.

Completed

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Key information

Conditions

Quality of Life

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole

Drug

1mg, orally, once daily

Other names: Arimidex

Tamoxifen

Drug

20mg, orally, once daily

Other names: Nolvadex

Primary outcomes

Time to withdrawal
Time to recurrence

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Double-Blind, Parallel Group Trial to Assess Quality of Life With Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women

Important dates

Study start: 1998
Study completion: 2004
First posted: Nov 4, 2008
Registry last updated: May 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed