Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments tamoxifen, anastrozole, zoledronic acid
Phase phase 3
Sponsor Austrian Breast & Colorectal Cancer Study Group
Collaborator AstraZeneca
Start date June 1999
End date December 2015
Trial size 1803 participants
Trial identifier NCT00295646, ABCSG-12, CZOL 446 1B 01, Zol-A-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronat; zoledronic acid)
anastrozole Arimidex
1 mg/d
zoledronic acid Zoledronate, Zometa
4 mg q6m
(Active Comparator)
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronat; zoledronic acid)
tamoxifen Nolvadex
20 mg/d
zoledronic acid Zoledronate, Zometa
4 mg q6m
(Active Comparator)
Study Drug Arimidex (Anastrozole)
anastrozole Arimidex
1 mg/d
(Active Comparator)
Study Drug Nolvadex (Tamoxifen)
tamoxifen Nolvadex
20 mg/d

Primary Outcomes

Measure
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.
time frame: 28.05.2008

Secondary Outcomes

Measure
For the assessment of the recurrence free survival (RFS) patients receiving tamoxifen will be compared to patients receiving anastrozole and patients receiving zoledronate will be compared to controls, respectively.
time frame: 28.05.2008
For the assessment of the overall survival (OS) patients receiving tamoxifen will be compared to patients receiving anastrozole and patients receiving zoledronate will be compared to controls, respectively.
time frame: 28.05.2008
The objective is 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 anti-estrogen or aromatase inhibitor (AI).
time frame: 28.05.2008
Adverse and severe adverse events will be listed for all therapy subgroups "anastrozole / zoledronate" (AZ), "anastrozole / zoledronate control" (AC), "tamoxifen / zoledronate" (TZ), "tamoxifen / zoledronate control" (TC).
time frame: 28.05.2008

Eligibility Criteria

Female participants from 19 years up to 59 years old.

Inclusion Criteria: - Premenopausal, hormone receptor-positive patient - Histologically verified (minimally) invasive breast cancer, local radical treatment - 0-9 involved axillary lymph nodes (≥ 10 histologically examined nodes) - Tumor stage: pT1b-3, yT0 or yT1a Exclusion Criteria: - T1a, T4d, yT4; M1 - Previous breast tumor irradiation - Previous or concurrent chemotherapy (except for preoperative chemotherapy) - Serum creatinine > 1.5 x UNL or creatinine clearance < 60 ml/min

Additional Information

Official title Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)
Principal investigator Raimund Jakesz, MD
Description 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 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 BMD measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres).
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Austrian Breast & Colorectal Cancer Study Group.