Stage IB Breast Cancer Clinical Trial
Official title:
A Pilot Study of the Impact of a Single Dose of Zoledronic Acid on Biomarkers in Breast Cancer
This pilot clinical trial studies biomarkers in tissue samples from patients with newly diagnosed breast cancer treated with zoledronic acid (ZA). Studying samples of tumor tissue in the laboratory from patients receiving ZA may help doctors learn more about the effects of ZA on cells. It may also help doctors understand how well patients respond to treatment.
PRIMARY OBJECTIVES:
I. To evaluate 14 tumor biomarkers of growth and metastasis (10 by microarray and 4 by
RT-PCR) for change in response to ZA.
SECONDARY OBJECTIVES:
I. To evaluate 30 measures of immunologic function (by Luminex panel) for change in response
to ZA a) after 48-72 hours and b) after 10-23 days.
II. To explore additional tumors biomarkers (approximately 20 by immunohistochemistry) for
change in response to ZA.
OUTLINE: Patients receive zoledronic acid intravenously (IV) over 15 minutes on day 1.
Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23.
Tissue and blood samples from the initial biopsy and definitive surgery are collected to
measure changes in biomarkers of tumor growth and metastasis, immunologic function, and the
expression of genes important to breast cancer progression and metastasis.
After completion of study treatment, patients are followed up at 40-44 days.
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