ATAC - Arimidex, Tamoxifen Alone or in Combination

NCT ID: NCT00849030

Last Updated: 2012-06-06

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

9358 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-07-31

Study Completion Date

2010-04-30

Brief Summary

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The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Arimidex 1mg + Nolvadex placebo

Group Type ACTIVE_COMPARATOR

Anastozole (Arimidex)

Intervention Type DRUG

1mg, orally, once daily

Tamoxifen (Nolvadex) placebo

Intervention Type DRUG

20mg, orally, once daily

2

Arimidex placebo + Nolvadex 20mg

Group Type ACTIVE_COMPARATOR

Tamoxifen (Nolvadex)

Intervention Type DRUG

20mg, orally, once daily

Anastozole (Arimidex) placebo

Intervention Type DRUG

1mg, orally, once daily

3

Arimidex 1mg + Nolvadex 20mg

Group Type ACTIVE_COMPARATOR

Anastozole (Arimidex)

Intervention Type DRUG

1mg, orally, once daily

Tamoxifen (Nolvadex)

Intervention Type DRUG

20mg, orally, once daily

Interventions

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Anastozole (Arimidex)

1mg, orally, once daily

Intervention Type DRUG

Tamoxifen (Nolvadex)

20mg, orally, once daily

Intervention Type DRUG

Anastozole (Arimidex) placebo

1mg, orally, once daily

Intervention Type DRUG

Tamoxifen (Nolvadex) placebo

20mg, orally, once daily

Intervention Type DRUG

Other Intervention Names

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Arimidex Nolvadex

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically proven operable invasive breast cancer
* Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy
* Women defined as post-menopausal

Exclusion Criteria

* Patients in whom there is any clinical evidence of metastatic disease
* Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
* Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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D5392C00029

Identifier Type: -

Identifier Source: secondary_id

1033IL/0029

Identifier Type: -

Identifier Source: org_study_id

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