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

Stopped early · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01409811

Run by

City of Hope Medical Center

People needed

9

Starts

2012-09-14

Expected to finish

2015-02-01

Last updated by the study team

2020-05-08

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.