Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Arimidex 1mg + Nolvadex placebo
- interventionNames
- Drug: Anastrozole
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Arimidex placebo + Nolvadex 20mg
- interventionNames
- Drug: Anastrozole
- Drug: Tamoxifen
- type
- ACTIVE_COMPARATOR
- label
- 3
- description
- Arimidex 1mg + Nolvadex 20mg
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available