ATAC - Arimidex, Tamoxifen Alone or in Combination

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Anastozole (Arimidex); Drug: Tamoxifen (Nolvadex) placebo; Drug: Tamoxifen (Nolvadex); Drug: Anastozole (Arimidex) placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00849030

1033IL/0029

D5392C00029

Details and patient eligibility

About

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

Enrollment: 9,358 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9,358 participants in 3 patient groups

1

Active Comparator group

Description:

Arimidex 1mg + Nolvadex placebo

Treatment:

Drug: Tamoxifen (Nolvadex) placebo

Drug: Anastozole (Arimidex)

2

Active Comparator group

Description:

Arimidex placebo + Nolvadex 20mg

Treatment:

Drug: Anastozole (Arimidex) placebo

Drug: Tamoxifen (Nolvadex)

3

Active Comparator group

Description:

Arimidex 1mg + Nolvadex 20mg

Treatment:

Drug: Tamoxifen (Nolvadex)

Drug: Anastozole (Arimidex)