ATAC - Pharmacokinetics (PK) Sub-Protocol

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Tamoxifen; Drug: Anastrozole

• Registration Number: NCT00784862
• Lead Sponsor: AstraZeneca

Brief Summary

To assess the effect of ARIMIDEX on the pharmacokinetics of tamoxifen and the effects of tamoxifen on the pharmacokinetics of ARIMIDEX..

Detailed Description

Not available

Study Timeline

• Study Start: 1998-06
• Study Completion: 1999-03
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-04
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-14
• Last Update Posted: 2009-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9358

Inclusion Criteria

• Eligible for entry into the main ATAC trial 1033IL/0029
• Patients must have been taking ATAC trial medication for at least 3 months (i.e. patients must have reached at least visit 2 of the main ATAC study)
• Patients should be taking their medication in the mornings for at least 3 months
• Patients must be 100% compliant over the preceding fourteen days

Exclusion Criteria

• Excluded from entry into the main ATAC trial (1033IL/0029)
• Patients whose concurrent treatment includes diazepam or drugs which might affect tamoxifen steady state levels or steroid hormone status. These include ketoconazole (antifungal) or related compounds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole	24±4 hours after previous dose