IRB Number:

06-002168

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This study is investigational and is being done to find out if adding a drug (a bisphosphonate) to hormonal therapy or chemotherapy will help prevent cancer from spreading to the bones or other parts of the body. Bisphosphonates are a group of drugs that have strong effects on the bones and have been shown to strengthen the bones in many patients who take them. This study will compare three study drugs, ibandronate, clodronate, and zoledronic acid in breast cancer.

Who is Eligible to Participate in the Study?

-Women diagnosed with Stage I, II, or III Breast Cancer
-Patients must receive standard adjuvant therapy for their breast cancer. Chemotherapy, hormone therapy, or combined chemo/hormone therapy is permitted.
-No more than 12 weeks since date of final surgical procedure

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

-Medical exams
-Weight and performance status
-Disease Assessment
-Blood tests
-Pregnancy test for women potentially able to have children
-CT and bone scans
-Dental examination

How long will the Study run?

-Patients will be randomized into 1 of 3 study groups. Randomization means that the patient is put into a group by chance. A computer program will place the patient in one of the study groups. Neither the patient nor the doctor can choose the group the patient will be in. The patient will have a 1-in-3 chance of being placed in any group.
-If the patient is in Group 1, they will be given 4 mg (or less based on how patient's kidneys are working) of zoledronic acid through a needle in a vein every 4 weeks for the first 6 months and then once every 3 months after that for 30 months.
-If the patient is in Group 2, the patient will take 1,600 mg of clodronate by mouth once a day, every day for 36 months.
-If the patient is in Group 3, the patient will take 50 mg of ibandronate by mouth once a day, every day for 36 months.
-When patient is finished with taking the study drugs, they will need to see the study doctor for a physical examination, and bone scan. Additionally, the patient will need to have a dental examination within 3 months of completing treatment.
-Patients will be in the study for 10 years. For the first 3 years, the patient will be asked to take bisphosphonates. After finishing taking bisphosphonates, the study doctor will ask the patient to visit the office for follow-up exams every year for a length of 7 years. The follow-up evaluation tests that are standard to cancer care will include a medical history, physical examination, and performance status.

Sponsor(s): Southwest Oncology Group (SWOG); Cancer Clinical Trials Support Unit (NCI)

Study Activation: 05/12/2006

IRB Review and Approval Date: 04/14/2006

Study Type: Treatment

Projected Accrual: 6000 patients

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: James Ingle, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 06/26/2009