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Clinical Trials (PDQ®)

  • First Published: 10/25/2003
  • Last Modified: 7/10/2012

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Clinical Trials (PDQ®)

Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Neoadjuvant or Adjuvant Chemotherapy and/or Hormonal Therapy With Versus Without Zoledronate in Women With Stage II or III Breast Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overOtherSHEFF-AZURE
EU-20315, ISRCTN79831382, BIG-1-04, NCT00072020

Trial Description

Purpose:

Zoledronate may delay or prevent the formation of bone metastases. It is not yet known whether chemotherapy and/or hormone therapy are more effective with or without zoledronate in preventing cancer recurrence and bone metastases in women with breast cancer.

This randomized phase III trial is studying giving chemotherapy and/or hormone therapy together with zoledronate to see how well they work compared to chemotherapy and/or hormone therapy alone in preventing cancer recurrence and bone metastases in women with stage II or stage III breast cancer.

Eligibility:

Eligibility criteria include the following:

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two groups.

Patients in group one will receive chemotherapy and/or hormone therapy. At the same time, they will receive an infusion of zoledronate every 3-4 weeks for six doses, every 3 months for eight doses, and then every 6 months for five doses.

Patients in group two will receive chemotherapy and/or hormonal therapy alone.

After finishing treatment, patients will be evaluated once a year for 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

University of Sheffield School of Medicine and Biomedical Sciences

Robert Coleman, MD, FRCP, Study coordinator
Ph: 44-114-226-5213
Email: r.e.coleman@sheffield.ac.uk
Victoria Hiley, Study coordinator
Ph: 44-113-343-1497
Email: v.l.hiley@leeds.ac.uk

Registry Information
Official Title Does Adjuvant Zoledronic Acid Reduce Recurrence in Patients with High Risk Localized Breast Cancer?
Trial Start Date 2003-08-18
Registered in ClinicalTrials.gov NCT00072020
Date Submitted to PDQ 2003-09-12
Information Last Verified 2006-01-23

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