NCT00814125

Brief Summary

To compare the difference between the ARIMIDEX group and the tamoxifen group in the incidence of abnormal endometrial histological findings arising after treatment has commenced.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
285

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Jun 1997

Typical duration 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, 1997

Completed
8.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 24, 2008

Completed
Last Updated

May 1, 2009

Status Verified

April 1, 2009

First QC Date

November 3, 2008

Last Update Submit

April 30, 2009

Conditions

Breast Cancer

Keywords

EndometrialEndometrial histological findings

Outcome Measures

Primary Outcomes (2)

  • Withdrawl

  • Death

Study Arms (3)

1

ACTIVE COMPARATOR

Arimidex 1mg + Nolvadex placebo

Drug: Anastrozole (Arimidex)Drug: Nolvadex placebo

2

ACTIVE COMPARATOR

Arimidex placebo + Nolvadex 20mg

Drug: Tamoxifen (Nolvadex)Drug: Arimidex placebo

3

ACTIVE COMPARATOR

Arimidex 1mg + Nolvadex 20mg

Drug: Anastrozole (Arimidex)Drug: Tamoxifen (Nolvadex)

Interventions

Anastrozole (Arimidex)DRUG

1mg, orally, once daily

Also known as: Arimidex
13
Tamoxifen (Nolvadex)DRUG

20mg, orally, once daily

Also known as: Nolvadex
23
Nolvadex placeboDRUG
1
Arimidex placeboDRUG
2

Eligibility Criteria

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

You may qualify if:

  • Patients eligible for entry into the main ATAC trial (1033IL/0029)
  • Not received any previous tamoxifen, for whatever reason
  • Not undergone a hysterectomy and do not have a hysterectomy planned within the next 6 years
  • No previous endometrial ablation

You may not qualify if:

  • Excluded from entry into the main ATAC trial (1033IL/0029). As detailed in Section 4.4 of the main ATAC trial (1033IL/0029)

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
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 3, 2008

First Posted

December 24, 2008

Study Start

June 1, 1997

Study Completion

December 1, 2005

Last Updated

May 1, 2009

Record last verified: 2009-04