ATAC - Endometrial 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

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-06-30

Study Completion Date

2005-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

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 (Arimidex)

Intervention Type DRUG

1mg, orally, once daily

Nolvadex placebo

Intervention Type DRUG

2

Arimidex placebo + Nolvadex 20mg

Group Type ACTIVE_COMPARATOR

Tamoxifen (Nolvadex)

Intervention Type DRUG

20mg, orally, once daily

Arimidex placebo

Intervention Type DRUG

3

Arimidex 1mg + Nolvadex 20mg

Group Type ACTIVE_COMPARATOR

Anastrozole (Arimidex)

Intervention Type DRUG

1mg, orally, once daily

Tamoxifen (Nolvadex)

Intervention Type DRUG

20mg, orally, once daily

Interventions

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Anastrozole (Arimidex)

1mg, orally, once daily

Intervention Type DRUG

Tamoxifen (Nolvadex)

20mg, orally, once daily

Intervention Type DRUG

Nolvadex placebo

Intervention Type DRUG

Arimidex placebo

Intervention Type DRUG

Other Intervention Names

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Arimidex Nolvadex

Eligibility Criteria

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Inclusion Criteria

* 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