Protocol Title

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer (SWOG S0307)

Description

The skeleton is the initial site of recurrence in 35-40% of patients with breast cancer. Up to 60-80% of metastatic breast cancer patients eventually develop signs and symptoms related to bone involvement. Bone metastases in breast cancer are associated with significant complications including pain, pathologic fractures, increased calcium levels, bone marrow suppression, and spinal cord compression.

This study proposes to find out whether two newer, potentially more potent bisphosphonates, zoledronic acid and ibandronate, can delay or prevent bone metastases compared with the control arm containing oral clodronate. About 6,000 participants will take part this study sponsored by the Southwest Oncology Group (SWOG).

If a participant meets the eligibility criteria and agrees to take part, she will be randomly assigned to one of three treatment groups: zoledronic acid, clodronate, or ibandronate. She will have an equal chance of being in any of the three groups. The participant will receive the assigned drug for 3 years.

Objectives

To compare disease-free and overall survival in patients receiving clodronate vs ibandronte vs zoledronic acid as adjuvant therapy for breast cancer

To compare the sites of first recurrence amongst the three treatments

To assess the side effects associated with the three treatments

Eligibility

Patient is at least 18 years of age.

Patient has a histological diagnosis of Stage I, II, or III breast cancer

Patients of childbearing potential must have a negative pregnancy test and agree to use an accepted method of non-hormonal contraception

Patient must have a dental exam within 6 months before registration

Patient must have adequate organ function and meet other guidelines for eligibility as specified by the protocol.

Contact

For the current eligibility status of and additional information about this clinical study, please contact Breastlink Clinical Research Group at 1-562-981-6101.

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