NCT00784680

Brief Summary

To compare Quality of Life between the ARIMIDEX group, the NOLVADEX group and the ARIMIDEX plus NOLVADEX combination group during the first two years of treatment. (a) To compare the difference in Quality of Life between the ARIMIDEX group and the NOLVADEX group (b) To compare Quality of Life in the ARIMIDEX plus NOLVADEX combination group with the NOLVADEX group for non-inferiority; if non inferiority is concluded, the difference in QOL between these two groups will be assessed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
308

participants targeted

Target at P75+ for phase_3 quality-of-life

Timeline
Completed

Started Apr 1998

Longer than P75 for phase_3 quality-of-life

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
4.6 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 1, 2009

Status Verified

April 1, 2009

First QC Date

November 3, 2008

Last Update Submit

April 30, 2009

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (2)

  • Time to withdrawal

  • Time to recurrence

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
  • Completion of a baseline questionnaire

You may not qualify if:

  • Excluded from entry into the main ATAC trial (1033IL/0029)
  • If, in the investigators opinion, the patient would be unable to comply with this sub-protocol due to psychiatric or literacy reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AnastrozoleTamoxifen

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

November 4, 2008

Study Start

April 1, 1998

Study Completion

April 1, 2004

Last Updated

May 1, 2009

Record last verified: 2009-04