Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid

• Changes in immunologic function after a single dose of zoledronic acid [ Time Frame: At baseline, 48-72 hours after zoledronic acid, and at the time of definitive surgery (21-24 days) ] [ Designated as safety issue: No ]
  We will apply the FDR-controlling procedure to immunological markers as one family. If change-in-endpoint data are not normally distributed, they will be transformed as appropriate.
• Changes in the expression of tumor markers important to breast cancer progression and metastasis in women receiving zoledronic acid [ Time Frame: From baseline to the time of definitive surgery (21-24 days) ] [ Designated as safety issue: No ]
  We will apply the FDR-controlling procedure to tumor markers assessed by immunohistochemistry as one family. If change-in-endpoint data are not normally distributed, they will be transformed as appropriate.

• Changes in immunologic function after a single dose of zoledronic acid [ Time Frame: At baseline, 48-72 hours after zoledronic acid, and at the time of definitive surgery (21-24 days) ] [ Designated as safety issue: No ]
• Changes in the expression of genes important to breast cancer progression and metastasis in women receiving zoledronic acid [ Time Frame: From baseline to the time of definitive surgery (21-24 days) ] [ Designated as safety issue: No ]

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 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..

• Estrogen Receptor-negative Breast Cancer
• Estrogen Receptor-positive Breast Cancer
• Invasive Ductal Breast Carcinoma
• Progesterone Receptor-negative Breast Cancer
• Progesterone Receptor-positive Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer

• Drug: zoledronic acid
  Given IV
  Other Names:

  • CGP 42446
  • CGP42446A
  • NDC-zoledronate
  • zoledronate
  • Zometa
• Other: laboratory biomarker analysis
  Correlative studies
• Procedure: therapeutic conventional surgery
  Undergo definitive lumpectomy or mastectomy

Inclusion Criteria:

• Postmenopausal women
• Early stage, invasive ductal carcinoma for which a lumpectomy or mastectomy is planned prior to systemic therapy
• Need for diagnostic biopsy (to determine the hormone receptor or human epidermal growth factor receptor 2 [Her2] status); or willing to undergo a second biopsy if their diagnostic biopsy was done outside of City of Hope
• 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
• Renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by the Cockroft-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)