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To Evaluate the Characteristics of a Breast Cancer

This study has been withdrawn prior to enrollment.
(PI left Duke)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055678
First Posted: January 26, 2010
Last Update Posted: December 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mark Dewhirst, Duke University Medical Center
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: EF5 Procedure: Partial or Total Mastectomy Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study to Characterize the HRHV Axis in the Microenvironment of Breast Cancers

Resource links provided by NLM:


Further study details as provided by Mark Dewhirst, Duke University Medical Center:

Primary Outcome Measures:
  • To evaluate tumor characteristics [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Intra and Interpatient correlations with tumor hypoxia [ Time Frame: 3 years ]

Enrollment: 0
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Patients
Single arm study analyzing tumor hypoxia after EF5 injection
Drug: 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.
Procedure: Partial or Total Mastectomy
A small tissue sample will be removed from the excised tissue and will be stored for later analysis.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055678


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Mark Dewhirst
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mark W Dewhirst, DVM, PhD Duke University
  More Information

Publications:
Responsible Party: Mark Dewhirst, Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01055678     History of Changes
Other Study ID Numbers: Pro00020382
R01CA040355 ( U.S. NIH Grant/Contract )
First Submitted: January 24, 2010
First Posted: January 26, 2010
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by Mark Dewhirst, Duke University Medical Center:
breast cancer
ductal breast carcinoma in situ
breast cancer in situ
invasive carcinoma
invasive ductal carcinoma
invasive lobular carcinoma

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases