ATAC - Endometrial Sub-Protocol

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Tamoxifen (Nolvadex); Drug: Anastrozole (Arimidex); Drug: Nolvadex placebo; Drug: Arimidex placebo

• Registration Number: NCT00814125
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-06
• Study Completion: 2005-12
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-12-23
• Study First Posted: 2008-12-24
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-30
• Last Update Posted: 2009-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 285

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Tamoxifen (Nolvadex)	Arimidex placebo + Nolvadex 20mg
3	Tamoxifen (Nolvadex)	Arimidex 1mg + Nolvadex 20mg
3	Anastrozole (Arimidex)	Arimidex 1mg + Nolvadex 20mg
1	Nolvadex placebo	Arimidex 1mg + Nolvadex placebo
2	Arimidex placebo	Arimidex placebo + Nolvadex 20mg
1	Anastrozole (Arimidex)	Arimidex 1mg + Nolvadex placebo

Primary Outcome Measures

Name	Time	Method
Withdrawl
Death