Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid
NCT ID: NCT01409811
Last Updated: 2020-05-08
Study Results
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View full resultsBasic Information
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TERMINATED
NA
9 participants
INTERVENTIONAL
2012-09-14
2015-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (zoledronic acid)
Patients receive a single dose of zoledronic acid 4 mg 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.
zoledronic acid: Given IV
laboratory biomarker analysis: Correlative studies
therapeutic conventional surgery: Undergo definitive lumpectomy or mastectomy
zoledronic acid
Given IV
laboratory biomarker analysis
Correlative studies
therapeutic conventional surgery
Undergo definitive lumpectomy or mastectomy
Interventions
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zoledronic acid
Given IV
laboratory biomarker analysis
Correlative studies
therapeutic conventional surgery
Undergo definitive lumpectomy or mastectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Joanne Mortimer
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2011-02137
Identifier Type: REGISTRY
Identifier Source: secondary_id
10192
Identifier Type: -
Identifier Source: org_study_id
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