ATAC - Quality of Life Sub-Protocol

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00784680

Enrollment

308

Registered

2008-11-04

Start date

1998-04-30

Completion date

2004-04-30

Last updated

2009-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

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.

Interventions

DRUGAnastrozole

1mg, orally, once daily

DRUGTamoxifen

20mg, orally, once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to withdrawal	—
Time to recurrence	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026