ATAC - Bone Density Sub-Protocol

Phase 3

Completed

• Conditions: Bone Density
• Interventions: Drug: Anastrozole; Drug: Tamoxifen

• Registration Number: NCT00784940
• Lead Sponsor: AstraZeneca

Brief Summary

To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-06
• Primary Completion: 2005-03
• Study Completion: 2007-04
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-04
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-24
• Last Update Posted: 2009-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 308

Inclusion Criteria

• Eligible for entry into the main ATAC trial 1033IL/0029
• Women defined as post-menopausal
• Patients with histologically proven operable invasive breast cancer
• Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated

Exclusion Criteria

• Excluded from entry into the main ATAC trial (1033IL/0029)
• Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
• Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
• Patients who have had a bone fracture within the previous 6 months prior to randomisation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time to withdrawal
Time to recurrence