ATAC - Pharmacokinetics (PK) Sub-Protocol

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00784862
First received: November 3, 2008
Last updated: May 14, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Anastrozole
Drug: Tamoxifen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole [ Time Frame: 24±4 hours after previous dose ] [ Designated as safety issue: Yes ]

Enrollment: 9358
Study Start Date: June 1998
Study Completion Date: March 1999
Arms Assigned Interventions
Active Comparator: 1
Arimidex 1mg + Nolvadex placebo
Drug: Anastrozole
1mg, orally, once daily
Other Name: Arimidex
Active Comparator: 2
Arimidex placebo + Nolvadex 20mg
Drug: Anastrozole
1mg, orally, once daily
Other Name: Arimidex
Drug: Tamoxifen
20mg, orally, once daily
Other Name: Nolvadex
Active Comparator: 3
Arimidex 1mg + Nolvadex 20mg
Drug: Tamoxifen
20mg, orally, once daily
Other Name: Nolvadex

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Francisco Sapunar, Medical Science Director, Arimidex and Faslodex, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00784862     History of Changes
Other Study ID Numbers: 1033IA/0029, D5392C02301
Study First Received: November 3, 2008
Last Updated: May 14, 2009
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Belgium: Ministry of Social Affairs, Public Health and the Environment
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Portugal: Ethics Committee for Clinical Research
Portugal: Health Ethic Committee
Portugal: National Pharmacy and Medicines Institute
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Anastrozole
Tamoxifen
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014