Clinical trial · Interventional
ATAC - Endometrial Sub-Protocol
A Randomised, Double Blind Trial to Assess the Incidence of Endometrial Changes With Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
NCT00814125CI-TRIAL-00002280completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 the difference between the ARIMIDEX group and the tamoxifen group in the incidence of abnormal endometrial histological findings arising after treatment has commenced.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole (Arimidex) | Drug | Anastrozole | ALIAS |
| Arimidex placebo | Drug | — | UNRESOLVED |
| Nolvadex placebo | Drug | — | UNRESOLVED |
| Tamoxifen (Nolvadex) | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Arimidex 1mg + Nolvadex placebo
- interventionNames
- Drug: Anastrozole (Arimidex)
- Drug: Nolvadex placebo
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Arimidex placebo + Nolvadex 20mg
- interventionNames
- Drug: Tamoxifen (Nolvadex)
- Drug: Arimidex placebo
- type
- ACTIVE_COMPARATOR
- label
- 3
- description
- Arimidex 1mg + Nolvadex 20mg
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Patients eligible for entry into the main ATAC trial (1033IL/0029) * Not received any previous tamoxifen, for whatever reason * Not undergone a hysterectomy and do not have a hysterectomy planned within the next 6 years * No previous endometrial ablation Exclusion Criteria: * Excluded from entry into the main ATAC trial (1033IL/0029). As detailed in Section 4.4 of the main ATAC trial (1033IL/0029)
References
Publications (0)
Data not yet available
No reference posted for this study.