ATAC - Pharmacokinetics (PK) Sub-Protocol

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784862
• Other study ID #: 1033IA/0029
• Secondary ID: D5392C02301
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2008
• Last updated: May 14, 2009
• Start date: June 1998
• Est. completion date: March 1999

Study information

• Verified date: May 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review BoardBelgium: Ministry of Social Affairs, Public Health and the EnvironmentBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlPortugal: Ethics Committee for Clinical ResearchPortugal: Health Ethic CommitteePortugal: National Pharmacy and Medicines InstituteSouth Africa: Medicines Control CouncilSouth Africa: National Health Research Ethics CouncilUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9358
• Est. completion date: March 1999
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Anastrozole
1mg, orally, once daily
• Tamoxifen
20mg, orally, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole		24±4 hours after previous dose	Yes