ATAC - Pharmacokinetics (PK) Sub-Protocol

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Anastrozole; Drug: Tamoxifen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00784862

1033IA/0029

D5392C02301

Details and patient eligibility

About

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

Enrollment: 9,358 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9,358 participants in 3 patient groups

1

Active Comparator group

Description:

Arimidex 1mg + Nolvadex placebo

Treatment:

Drug: Anastrozole

2

Active Comparator group

Description:

Arimidex placebo + Nolvadex 20mg

Treatment:

Drug: Tamoxifen

Drug: Anastrozole

3

Active Comparator group

Description:

Arimidex 1mg + Nolvadex 20mg

Treatment:

Drug: Tamoxifen