ATAC - Quality of Life Sub-Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2004-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Arimidex 1mg + Nolvadex placebo

Group Type ACTIVE_COMPARATOR

Anastrozole

Intervention Type DRUG

1mg, orally, once daily

2

Arimidex placebo + Nolvadex 20mg

Group Type ACTIVE_COMPARATOR

Anastrozole

Intervention Type DRUG

1mg, orally, once daily

Tamoxifen

Intervention Type DRUG

20mg, orally, once daily

3

Arimidex 1mg + Nolvadex 20mg

Group Type ACTIVE_COMPARATOR

Tamoxifen

Intervention Type DRUG

20mg, orally, once daily

Interventions

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Anastrozole

1mg, orally, once daily

Intervention Type DRUG

Tamoxifen

20mg, orally, once daily

Intervention Type DRUG

Other Intervention Names

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Arimidex Nolvadex

Eligibility Criteria

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Inclusion Criteria

* Eligible for entry into the main ATAC trial 1033IL/0029
* Completion of a baseline questionnaire

Exclusion Criteria

* 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

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No