Spots Global Cancer Trial Database for Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer

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Trial Identification

Brief Title: Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer

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

Study ID: NCT00295867

Conditions

Breast Cancer

Interventions

Zoledronic Acid

Study Description

Brief Summary: 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.

Detailed Description: 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.