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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
45
Zoledronic acid is a new, highly potent, heterocyclic nitrogen-containing third generation bisphosphonate that has demonstrated 40- to 850- fold greater potency than pamidronate in preclinical models of bone resorption. The mechanism of action of nitrogen-containing bisphosphonates such as pamidronate and zoledronic acid appears to involve inhibition of the mevalonate pathway
University of California, San Francisco
San Francisco, California, United States
Response of Bone Marrow Micrometastases
Median change in disseminated tumor cells (DTCs)/mL from baseline after 24 months
Time frame: up to 2 years
Change in N-telopeptide Level
N-telopeptide levels in urine will be recorded to evaluate the effect of zoledronic acid on bone mineralization (nmol bone collagen equivalents/mmol creatinine) at baseline and after 24 months on study treatment
Time frame: up to 2 years
Number of Patients With Incidences of Distant Recurrence
Distant breast cancer recurrence is when the cancer has spread to another organ within the body.
Time frame: up to 5 years post initiation of treatment
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