To Evaluate the Characteristics of a Breast Cancer

This study has been withdrawn prior to enrollment.
(PI left Duke)
Information provided by (Responsible Party):
Mark Dewhirst, Duke University Medical Center Identifier:
First received: January 24, 2010
Last updated: December 14, 2012
Last verified: December 2012

January 24, 2010
December 14, 2012
January 2010
December 2011   (final data collection date for primary outcome measure)
To evaluate tumor characteristics [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To evaluate tumor characteristics [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01055678 on Archive Site
Intra and Interpatient correlations with tumor hypoxia [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
To Evaluate the Characteristics of a Breast Cancer
Pilot Study to Characterize the HRHV Axis in the Microenvironment of Breast Cancers

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.

Not Provided
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • 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.
Experimental: All Patients
Single arm study analyzing tumor hypoxia after EF5 injection
  • Drug: EF5
  • Procedure: Partial or Total Mastectomy

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
December 2011   (final data collection date for primary outcome measure)

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
Pro00020382, R01CA040355
Mark Dewhirst, Duke University Medical Center
Mark Dewhirst
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Principal Investigator: Mark W Dewhirst, DVM, PhD Duke University
Duke University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP