To Evaluate the Characteristics of a Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | September 2011 |
| End Date: | December 2014 |
| Contact: | Jennifer Gallagher, BA |
| Email: | jennifer.gallagher@duke.edu |
| Phone: | 919-660-8222 |
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.
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
We found this trial at
1
site
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
