ATAC - Pharmacokinetics (PK) Sub-Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

9358 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-06-30

Study Completion Date

1999-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Arimidex 1mg + Nolvadex placebo

Group Type ACTIVE_COMPARATOR

Anastrozole

Intervention Type DRUG

1mg, orally, once daily

2

Arimidex placebo + Nolvadex 20mg

Group Type ACTIVE_COMPARATOR

Anastrozole

Intervention Type DRUG

1mg, orally, once daily

Tamoxifen

Intervention Type DRUG

20mg, orally, once daily

3

Arimidex 1mg + Nolvadex 20mg

Group Type ACTIVE_COMPARATOR

Tamoxifen

Intervention Type DRUG

20mg, orally, once daily

Interventions

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Anastrozole

1mg, orally, once daily

Intervention Type DRUG

Tamoxifen

20mg, orally, once daily

Intervention Type DRUG

Other Intervention Names

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Arimidex Nolvadex

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No