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

Alternate Title

Phase III Randomized Study of Zoledronate, Calcium, and Cholecalciferol (Vitamin D) to Prevent Bone Loss in Women With Breast Cancer Receiving Adjuvant Chemotherapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Closed	40 and over	NCI	CALGB-79809 NCI-P01-0184, NCT00022087

Trial Description

Purpose:

Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss.

This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer.

Eligibility:

Eligibility criteria include the following:

• At least 40 years old
• Not menopausal
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

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

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in both groups will begin treatment either on day 1 of adjuvant chemotherapy or within 3 months after day 1 of adjuvant chemotherapy.

Patients in group one will receive an infusion of zoledronate every 3 months for 2 years. Beginning at the same time, they will also receive calcium and vitamin D by mouth once a day for 3 years.

Patients in group two will receive calcium and vitamin D by mouth as in group one. After 1 year, these patients will also receive an infusion of zoledronate every 3 months for 2 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

Cancer and Leukemia Group B

Charles Shapiro, MD, Protocol chair		Ph: 614-293-6401 Email: charles.shapiro@osumc.edu

Registry Information
Official Title		Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients with Chemotherapy-Induced Ovarian Failure
Trial Start Date		2001-12-15
Registered in ClinicalTrials.gov		NCT00022087
Date Submitted to PDQ		2001-06-06
Information Last Verified		2006-03-11
NCI Grant/Contract Number		CA31946

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