ATAC - Quality of Life Sub-Protocol

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Quality of Life

Treatments: Drug: Anastrozole; Drug: Tamoxifen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00784680

1033IE/0029

D5392C08389

Details and patient eligibility

About

To compare Quality of Life between the ARIMIDEX group, the NOLVADEX group and the ARIMIDEX plus NOLVADEX combination group during the first two years of treatment. (a) To compare the difference in Quality of Life between the ARIMIDEX group and the NOLVADEX group (b) To compare Quality of Life in the ARIMIDEX plus NOLVADEX combination group with the NOLVADEX group for non-inferiority; if non inferiority is concluded, the difference in QOL between these two groups will be assessed.

Enrollment: 308 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible for entry into the main ATAC trial 1033IL/0029
• Completion of a baseline questionnaire

Exclusion criteria

• Excluded from entry into the main ATAC trial (1033IL/0029)
• If, in the investigators opinion, the patient would be unable to comply with this sub-protocol due to psychiatric or literacy reasons

Trial design

308 participants in 3 patient groups

1

Active Comparator group

Description:

Arimidex 1mg + Nolvadex placebo

Treatment:

Drug: Anastrozole

2

Active Comparator group

Description:

Arimidex placebo + Nolvadex 20mg

Treatment:

Drug: Tamoxifen

Drug: Anastrozole

3

Active Comparator group

Description:

Arimidex 1mg + Nolvadex 20mg

Treatment:

Drug: Tamoxifen