ATAC - Quality of Life Sub-Protocol
NCT00784680 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 308
Last updated 2009-05-01
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.
Conditions
- Quality of Life
Interventions
- DRUG
-
Anastrozole
1mg, orally, once daily
- DRUG
-
Tamoxifen
20mg, orally, once daily
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1998-04-30
- Completion
- 2004-04-30
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