Status:
TERMINATED
Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Estrogen Receptor-positive Breast Cancer
Invasive Ductal Breast Carcinoma
Eligibility:
FEMALE
Phase:
NA
Brief 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 fr...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 14 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01409811
Start Date
September 14 2012
End Date
February 1 2015
Last Update
May 8 2020
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010