Breast Cancer Clinical Trial
Official title:
Pilot Study to Evaluate the Effect of Zoledronic Acid (Zometa) on Occult Malignant Bone Marrow Cells in Patients With High Risk Early Stage Breast Cancer
RATIONALE: Zoledronate may delay or prevent bone marrow metastases in patients with breast
cancer.
PURPOSE: This phase II trial is studying how well zoledronate works in treating bone marrow
micrometastases in women with stage I, stage II, or stage III breast cancer.
OBJECTIVES:
Primary
- Determine the response of bone marrow micrometastases, as measured by
immunocytochemistry/flow cytometry (IC/FC), during and after 2 years of treatment with
zoledronate in women with stage I-III breast cancer.
Secondary
- Evaluate the effects of zoledronate on the bone osteoclast activation marker,
n-telopeptide, in these patients.
- Evaluate the incidence of distant recurrences in high-risk women with early-stage breast
cancer and bone marrow micrometastases who receive adjuvant zoledronate.
OUTLINE: This is a pilot study.
Patients receive zoledronate IV over 15 minutes once a month for 2 years in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
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