NCT01409811

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

A Pilot Study of the Impact of a Single Dose of Zoledronic Acid on Biomarkers in Breast Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Estrogen Receptor-positive Breast Cancer
• Invasive Ductal Breast Carcinoma
• Progesterone Receptor-positive Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer

Interventions

Type	Name	Description
DRUG	zoledronic acid	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
PROCEDURE	therapeutic conventional surgery	Undergo definitive lumpectomy or mastectomy

Timeline

• Start date: 2012-09-14
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2011-08-04
• Last updated: 2020-05-08
• Results posted: 2020-04-28

Locations

1 site across 1 country: United States