CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,803 enrolled
Drug / intervention
tamoxifen +3 moredrug
Likely dose
tamoxifen 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00295646
NCT00295646Phase 3Completed

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

Austrian Breast & Colorectal Cancer Study Group·interventional·Posted Feb 24, 2006·Updated Mar 15, 2024

In Brief

A Phase 3 clinical trial evaluating tamoxifen, anastrozole, and 2 other interventions for Breast Cancer. Completed, enrolled 1,803 participants across 72 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustria, Germany

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 24, 2006
Enrollment StartJun 1, 1999
Primary CompletionMar 27, 2008
Study CompletionJun 26, 2018
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 20.4 years ago

Interventions

tamoxifendrug

20 mg/d

anastrozoledrug

1 mg/d

zoledronic aciddrug

4 mg q6m

goserelinother

3.6 mg goserelin subcutaneously every 28 days