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Estrogen Receptor-positive Breast Cancer | Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid

Estrogen Receptor-positive Breast Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

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

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:zoledronic acidGiven IV

Other:laboratory biomarker analysisCorrelative studies

Procedure:therapeutic conventional surgeryUndergo definitive lumpectomy or mastectomy

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Treatment (zoledronic acid)Patients receive zoledronic acid IV over 15 minutes on day 1. Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-14. 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.

Study Status

Active, not recruiting

Start Date: September 14, 2012

Completed Date: May 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Changes in biomarkers of tumor growth and metastasis in women with newly diagnosed ER and/or PR positive invasive ductal breast cancer receiving zoledronic acid

Secondary Outcome: Changes in immunologic function after a single dose of zoledronic acid

Study sponsors, principal investigator, and references

Principal Investigator: Joanne Mortimer

Lead Sponsor: City of Hope Medical Center

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT01409811

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