ATAC - Pharmacokinetics (PK) Sub-Protocol

AstraZeneca9,358 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

9,358

Conditions

Breast Cancer

Interventions

AnastrozoleDRUG

1mg, orally, once daily

TamoxifenDRUG

20mg, orally, once daily

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole

Time frame: 24±4 hours after previous dose

Data from ClinicalTrials.gov

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