NCT00295646

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,803 (actual)
• Sponsor: Austrian Breast & Colorectal Cancer Study Group · Network
• Sex: Female
• Age: 19 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor.

Detailed description

The trial is conducted as an open multi-center phase III study, in a two-factorial study design and according to Good Clinical Practice (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 plus zoledronate). Zoledronate will be administered by i.v. injection at a dose of 4 mg/month for the treatment period of 3 years. Five Bone Mineral Density (BMD) measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	tamoxifen	20 mg/d
DRUG	anastrozole	1 mg/d
DRUG	zoledronic acid	4 mg q6m
OTHER	goserelin	3.6 mg goserelin subcutaneously every 28 days

Timeline

• Start date: 1999-06-01
• Primary completion: 2008-03-27
• Completion: 2018-06-26
• First posted: 2006-02-24
• Last updated: 2024-03-15
• Results posted: 2024-03-15

Locations

72 sites across 2 countries: Austria, Germany