Skip to main content
OpenTrials
Completed

NCT Number: NCT00784862

ATAC - Pharmacokinetics (PK) Sub-Protocol

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole

Drug

1mg, orally, once daily

Other names: Arimidex

Tamoxifen

Drug

20mg, orally, once daily

Other names: Nolvadex

Primary outcomes

  1. Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole

    Time frame: 24±4 hours after previous dose

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
1998
Study completion
1999
First posted
Nov 4, 2008
Registry last updated
May 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.