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Pilot Study to Characterize the HRHV Axis in the Microenvironment of Breast Cancers


Phase 0
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Pilot Study to Characterize the HRHV Axis in the Microenvironment of Breast Cancers


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To evaluate tumor characteristics

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Mark W Dewhirst, DVM, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

Pro00020382

NCT ID:

NCT01055678

Start Date:

January 2010

Completion Date:

December 2011

Related Keywords:

  • Breast Cancer
  • breast cancer
  • ductal breast carcinoma in situ
  • breast cancer in situ
  • invasive carcinoma
  • invasive ductal carcinoma
  • invasive lobular carcinoma
  • Breast Neoplasms

Name

Location
Duke University Medical Center Durham, North Carolina  27710