Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)
The trial is conducted as an open multi-center phase III study, in a two-factorial study
design and according to GCP guidelines. Patients will be randomly assigned to a total of 4
study groups in a 1:1:1:1 assignment ratio. Several stratification criteria will be used in
order to ensure balanced distribution of known risk factors.
A total of 1.803 patients will be enrolled in 4 arms. Patients will either be treated with
anastrozole (1mg daily for 3 years) or tamoxifen (20mg daily for 3 years), and will
additionally receive either zoledronate (8mg q4 weeks for 3 years) or no zoledronate (arm A:
Nolvadex alone; arm B: Nolvadex plus zoledronate; arm C: Arimidex alone; arm D: Arimidex
Zoledronate will be administered by i.v. injection at a dose of 4 mg/month for the treatment
period of 3 years. Five BMD measurements will be performed in a subgroup of patients (404
patients, enrolled in 3 centres).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of tamoxifen with anastrozole in premenopausal patients with non-metastatic breast cancer and comparison of a subgroup additionally treated with zoledronate to a control subgroup without receiving zoledronate according to DFS.
Raimund Jakesz, MD
Austrian Breast & Colorectal Cancer Study Group
Austria: Federal Office for Safety in Health Care