ATAC - Pharmacokinetics (PK) Sub-Protocol

May 14, 2009 updated by: AstraZeneca

A Randomised, Double Blind Trial to Assess the Pharmacokinetics of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9358

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Arimidex 1mg + Nolvadex placebo
Drug: Anastrozole
1mg, orally, once daily
Other Names:
  • Arimidex
Active Comparator: 2
Arimidex placebo + Nolvadex 20mg
Drug: Anastrozole
1mg, orally, once daily
Other Names:
  • Arimidex
Drug: Tamoxifen
20mg, orally, once daily
Other Names:
  • Nolvadex
Active Comparator: 3
Arimidex 1mg + Nolvadex 20mg
Drug: Tamoxifen
20mg, orally, once daily
Other Names:
  • Nolvadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole
Time Frame: 24±4 hours after previous dose
24±4 hours after previous dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Study Completion (Actual)

March 1, 1999

Study Registration Dates

First Submitted

November 3, 2008

First Submitted That Met QC Criteria

November 3, 2008

First Posted (Estimate)

November 4, 2008

Study Record Updates

Last Update Posted (Estimate)

May 15, 2009

Last Update Submitted That Met QC Criteria

May 14, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1033IA/0029
  • D5392C02301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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