ATAC - Bone Density Sub-Protocol

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Bone Density

Treatments: Drug: Tamoxifen; Drug: Anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00784940

1033ID/0029

D5392C01985

Details and patient eligibility

About

To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.

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
• Women defined as post-menopausal
• Patients with histologically proven operable invasive breast cancer
• Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated

Exclusion criteria

• Excluded from entry into the main ATAC trial (1033IL/0029)
• Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
• Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
• Patients who have had a bone fracture within the previous 6 months prior to randomisation

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: Anastrozole

Drug: Tamoxifen

3

Active Comparator group

Description:

Arimidex 1mg + Nolvadex 20mg

Treatment:

Drug: Tamoxifen