Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid
This study is currently recruiting participants.
Verified December 2012 by City of Hope Medical Center
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01409811
First received: August 3, 2011
Last updated: December 14, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Estrogen Receptor-negative Breast Cancer Estrogen Receptor-positive Breast Cancer Invasive Ductal Breast Carcinoma Progesterone Receptor-negative Breast Cancer Progesterone Receptor-positive Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer |
Drug: zoledronic acid Other: laboratory biomarker analysis Procedure: therapeutic conventional surgery |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of the Impact of a Single Dose of Zoledronic Acid on Biomarkers in Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Zoledronic acid
U.S. FDA Resources
Further study details as provided by City of Hope Medical Center:
Primary Outcome Measures:
- 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 [ Time Frame: From baseline to the time of definitive surgery (day 21-24) ] [ Designated as safety issue: No ]We have identified 14 tumor biomarkers as primary endpoints and will control the false discover rate (FDR) among these by applying the sequential Bonferroni-type multiple testing procedure of Benjamini and Hochberg (1995).
Secondary Outcome Measures:
- Changes in immunologic function after a single dose of zoledronic acid [ Time Frame: At baseline, 48-72 hours after zoledronic acid, and at the time of definitive surgery (21-24 days) ] [ Designated as safety issue: No ]We will apply the FDR-controlling procedure to immunological markers as one family. If change-in-endpoint data are not normally distributed, they will be transformed as appropriate.
- Changes in the expression of tumor markers important to breast cancer progression and metastasis in women receiving zoledronic acid [ Time Frame: From baseline to the time of definitive surgery (21-24 days) ] [ Designated as safety issue: No ]We will apply the FDR-controlling procedure to tumor markers assessed by immunohistochemistry as one family. If change-in-endpoint data are not normally distributed, they will be transformed as appropriate.
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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 21-24. Tissue 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.
|
Drug: zoledronic acid
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Procedure: therapeutic conventional surgery
Undergo definitive lumpectomy or mastectomy
|
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 immunologic function (by Luminex panel) for change in response to ZA a) after 48-72 hours and b) after 21-24 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 21-24. Tissue 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..
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Postmenopausal women
- Early stage, invasive ductal carcinoma for which a lumpectomy or mastectomy is planned prior to systemic therapy
- Need for diagnostic biopsy (to determine the hormone receptor or human epidermal growth factor receptor 2 [Her2] status); or willing to undergo a second biopsy if their diagnostic biopsy was done outside of City of Hope
- 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
- Renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by the Cockroft-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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409811
Locations
| United States, California | |
| City of Hope Medical Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Joanne E. Mortimer, MD 800-826-4673 jmortimer@coh.org | |
| Principal Investigator: Joanne E. Mortimer, MD | |
Sponsors and Collaborators
City of Hope Medical Center
Investigators
| Principal Investigator: | Joanne Mortimer | City of Hope Medical Center |
More Information
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT01409811 History of Changes |
| Other Study ID Numbers: | 10192, NCI-2011-02137 |
| Study First Received: | August 3, 2011 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Carcinoma, Ductal, Breast Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Carcinoma, Ductal Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013