NCT00784862

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,358

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
Completed

Started Jun 1998

Shorter than P25 for phase_3 breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1999

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2008

Completed
Last Updated

May 15, 2009

Status Verified

May 1, 2009

First QC Date

November 3, 2008

Last Update Submit

May 14, 2009

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole

    24±4 hours after previous dose

Study Arms (3)

1

ACTIVE COMPARATOR

Arimidex 1mg + Nolvadex placebo

Drug: Anastrozole

2

ACTIVE COMPARATOR

Arimidex placebo + Nolvadex 20mg

Drug: AnastrozoleDrug: Tamoxifen

3

ACTIVE COMPARATOR

Arimidex 1mg + Nolvadex 20mg

Drug: Tamoxifen

Interventions

AnastrozoleDRUG

1mg, orally, once daily

Also known as: Arimidex
12
TamoxifenDRUG

20mg, orally, once daily

Also known as: Nolvadex
23

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AnastrozoleTamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 4, 2008

Study Start

June 1, 1998

Study Completion

March 1, 1999

Last Updated

May 15, 2009

Record last verified: 2009-05