Study identifier:1033IE/0029
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Quality of Life
Phase 3
No
Anastrozole, Tamoxifen
Female
308
Interventional
45 Years +
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verified 01 Dec 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
No locations available
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 |
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