To Evaluate the Characteristics of a Breast Cancer
Status:
Withdrawn
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Mark Dewhirst
Collaborators:
National Cancer Institute (NCI) National Institutes of Health (NIH)