ATAC - Quality of Life Sub-Protocol
Study identifier:1033IE/0029
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official 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
Medical condition
Quality of Life
Phase
Phase 3
Healthy volunteers
No
Study drug
Anastrozole, Tamoxifen
Sex
Female
Actual Enrollment
308
Study type
Interventional
Age
45 Years +
Date
Study Start Date: 01 Apr 1998
Primary Completion Date: -
Study Completion Date: 01 Apr 2004
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verification:
Verified 01 Dec 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Arimidex 1mg + Nolvadex placebo | Drug: Anastrozole 1mg, orally, once daily Other Name: Arimidex |
| Active Comparator: 2 Arimidex placebo + Nolvadex 20mg | Drug: Anastrozole 1mg, orally, once daily Other Name: Arimidex Drug: Tamoxifen 20mg, orally, once daily Other Name: Nolvadex |
| Active Comparator: 3 Arimidex 1mg + Nolvadex 20mg | Drug: Tamoxifen 20mg, orally, once daily Other Name: Nolvadex |
