ATAC - Arimidex, Tamoxifen Alone or in Combination

Study Overview
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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.

Official Title
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A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Anastozole (Arimidex)
* Drug: Tamoxifen (Nolvadex)
* Drug: Anastozole (Arimidex) placebo
* Drug: Tamoxifen (Nolvadex) placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Arimidex 1mg + Nolvadex placebo | Drug: Anastozole (Arimidex)<br>* 1mg, orally, once daily<br>* Other names: Arimidex;Drug: Tamoxifen (Nolvadex) placebo<br>* 20mg, orally, once daily<br>|
| Active Comparator: 2<br>Arimidex placebo + Nolvadex 20mg | Drug: Tamoxifen (Nolvadex)<br>* 20mg, orally, once daily<br>* Other names: Nolvadex;Drug: Anastozole (Arimidex) placebo<br>* 1mg, orally, once daily<br>|
| Active Comparator: 3<br>Arimidex 1mg + Nolvadex 20mg | Drug: Anastozole (Arimidex)<br>* 1mg, orally, once daily<br>* Other names: Arimidex;Drug: Tamoxifen (Nolvadex)<br>* 20mg, orally, once daily<br>* Other names: Nolvadex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence of breast cancer |  | Earliest of local or distant recurrence, new primary breast cancer, or death | 
| Safety and side effects |  | Earliest of local or distant recurrence, new primary breast cancer, or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to distant recurrence |  | Earliest of local or distant recurrence, new primary breast cancer, or death | 
| Survival |  | Earliest of local or distant recurrence, new primary breast cancer, or death | 
| New breast primaries |  | Earliest of local or distant recurrence, new primary breast cancer, or death |