Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid
Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid
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.
Inclusion Criteria:

 -  Postmenopausal women

 -  Diagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or
 mastectomy is planned prior to systemic therapy)

 -  Estrogen receptor (ER)/progesterone receptor (PR) positive tumor (as confirmed by City
 of Hope Pathology Department if done on the outside) or

 -  Biopsy proven ER/PR positive tumor

 -  Ability to provide informed consent

 Exclusion Criteria:

 -  Tumor that lacks both estrogen and progesterone receptors

 -  Patients who will receive neoadjuvant therapy prior to definitive surgery

 -  Bisphosphonate therapy currently or within the past 12 months

 -  Regular use of anti-inflammatory agents, with the exception of a baby aspirin regimen
 per principal investigator's (PI's) discretion

 -  Renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by
 the Cockcroft-Gault formula using the patient's actual weight

 -  Current active dental problems including infection of the teeth or jawbone (maxilla or
 mandibular); dental or fixture trauma, or a current or prior diagnosis of
 osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after
 dental procedures

 -  Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)