ATAC - Pharmacokinetics (PK) Sub-Protocol

• Status: Completed
• Trial end date: 1999-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Anastrozole; Tamoxifen

Criteria

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