ATAC - Arimidex, Tamoxifen Alone or in Combination

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Anastozole (Arimidex); Drug: Tamoxifen (Nolvadex); Drug: Tamoxifen (Nolvadex) placebo; Drug: Anastozole (Arimidex) placebo

• Registration Number: NCT00849030
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Study Timeline

• Study Start: 1996-07
• Primary Completion: 2001-06
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Study Completion: 2010-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9358

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Tamoxifen (Nolvadex) placebo	Arimidex 1mg + Nolvadex placebo
1	Anastozole (Arimidex)	Arimidex 1mg + Nolvadex placebo
2	Tamoxifen (Nolvadex)	Arimidex placebo + Nolvadex 20mg
2	Anastozole (Arimidex) placebo	Arimidex placebo + Nolvadex 20mg
3	Anastozole (Arimidex)	Arimidex 1mg + Nolvadex 20mg
3	Tamoxifen (Nolvadex)	Arimidex 1mg + Nolvadex 20mg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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