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Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

NCT00295646 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1803

Last updated 2024-03-15

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Raimund Jakesz, MD · Austrian Breast & Colorectal Cancer Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-06-30
Primary Completion
2008-03-27
Completion
2018-06-26

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00295646 on ClinicalTrials.gov