A Pilot Study of the Impact of a Single Dose of Zoledronic Acid on Biomarkers in Breast Cancer
I. To evaluate 14 tumor biomarkers of growth and metastasis (10 by microarray and 4 by
RT-PCR) for change in response to ZA.
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 21-24 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 21-24.
Tissue 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..
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Changes in biomarkers of tumor growth and metastasis in women with newly diagnosed ER and/or PR positive invasive ductal breast cancer receiving zoledronic acid
We have identified 14 tumor biomarkers as primary endpoints and will control the false discover rate (FDR) among these by applying the sequential Bonferroni-type multiple testing procedure of Benjamini and Hochberg (1995).
From baseline to the time of definitive surgery (day 21-24)
City of Hope Medical Center
United States: Federal Government
|City of Hope Medical Center||Duarte, California 91010|