Overview

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

Status:
Terminated
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
City of Hope Medical Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Diphosphonates
Zoledronic Acid
Criteria
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)