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To Evaluate the Characteristics of a Breast Cancer

NCT ID: NCT01055678

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the breast cancer tumor microenvironment. The study is based around four cornerstone features of the pathologic microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1 and VEGF, which we term the HRHV axis. Fifty breast cancer patients with planned surgical excision will be administered the hypoxia marker drug, EF5, 24-36 hr prior to surgical excision. EF5 is a non-therapeutic drug and provides no direct benefit to those patients enrolled in this pilot study. Tissues obtained intra-operatively will be snap frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the HRHV axis will be examined. The association of the markers with the presence of hypoxia, as determined by EF5 positivity, will be determined. Data from this pilot study will be used to establish the prevalence of markers of the HRHV axis in breast cancer. This information will be crucial for future human trials in which the HRHV axis is therapeutically targeted.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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breast cancer ductal breast carcinoma in situ breast cancer in situ invasive carcinoma invasive ductal carcinoma invasive lobular carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All Patients

Single arm study analyzing tumor hypoxia after EF5 injection

Group Type EXPERIMENTAL

EF5

Intervention Type DRUG

An infusion of EF5, a fluorinated 2-nitroimidazole, will be administered using the recommended dose of 21mg/kg one day prior to surgical procedure.

Partial or Total Mastectomy

Intervention Type PROCEDURE

A small tissue sample will be removed from the excised tissue and will be stored for later analysis.

Interventions

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EF5

An infusion of EF5, a fluorinated 2-nitroimidazole, will be administered using the recommended dose of 21mg/kg one day prior to surgical procedure.

Intervention Type DRUG

Partial or Total Mastectomy

A small tissue sample will be removed from the excised tissue and will be stored for later analysis.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed Stage 0 - III invasive carcinoma of the breast
* Tumor size greater than 1-cm by radiological (mammogram/ultrasound or MRI) evaluation
* KPS status ≥ 70
* Bilirubin ≤ 1.5x normal
* Creatinine ≤ 1.8
* WBC \> 3000/mm\^3 and platelets \> 100,000/mm\^3

Exclusion Criteria

* Pregnant or breast-feeding women
* Neoadjuvant chemo or hormonal therapy for existent breast malignancy
* Allergy to IV contrast dye
* History of grade III or IV peripheral neuropathy as defined by the NCI CTC
* Previous history of any malignancy treated with radiotherapy and/or chemohormonal therapy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Mark Dewhirst

OTHER

Sponsor Role lead

Responsible Party

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Mark Dewhirst

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mark W Dewhirst, DVM, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Dewhirst MW, Cao Y, Moeller B. Cycling hypoxia and free radicals regulate angiogenesis and radiotherapy response. Nat Rev Cancer. 2008 Jun;8(6):425-37. doi: 10.1038/nrc2397.

Reference Type BACKGROUND
PMID: 18500244 (View on PubMed)

Koch CJ, Hahn SM, Rockwell K Jr, Covey JM, McKenna WG, Evans SM. Pharmacokinetics of EF5 [2-(2-nitro-1-H-imidazol-1-yl)-N-(2,2,3,3,3-pentafluoropropyl) acetamide] in human patients: implications for hypoxia measurements in vivo by 2-nitroimidazoles. Cancer Chemother Pharmacol. 2001 Sep;48(3):177-87. doi: 10.1007/s002800100324.

Reference Type BACKGROUND
PMID: 11592338 (View on PubMed)

Other Identifiers

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R01CA040355

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00020382

Identifier Type: -

Identifier Source: org_study_id