To Evaluate the Characteristics of a Breast Cancer

This study has been withdrawn prior to enrollment.
(PI left Duke)
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Mark Dewhirst, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01055678
First received: January 24, 2010
Last updated: December 14, 2012
Last verified: December 2012
  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
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Duke University:

Primary Outcome Measures:
  • To evaluate tumor characteristics [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intra and Interpatient correlations with tumor hypoxia [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055678

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Mark Dewhirst
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
Study First Received: January 24, 2010
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
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

ClinicalTrials.gov processed this record on August 26, 2014