District of Columbia
This study, conducted by the NCI and the George Washington University Medical Center
(GWUMC), will examine breast tissue from patients with inflammatory breast cancer (IBC) for
tumor markers and factors associated with angiogenesis. Angiogenesis is the formation of new
blood vessels that is essential for tumor growth and spread. IBC is an extremely rare,
aggressive form of breast cancer that disproportionately affects young women. The risk
factors for IBC, its cause, and how it develops are unknown, but the disease appears to
involve a high degree of angiogenesis.
Tissue specimens for this study will be obtained from GWUMC's Inflammatory Breast Cancer
Registry and Biospecimen Repository. The registry was established to develop a national
registry of patients with IBC that includes standardized clinical, epidemiological, and
pathological information, along with disease recurrence and survival data.
For this study, tissue specimens from the repository will be tested for biological markers
and angiogenesis parameters to help in the classification of the tumors. Biological markers
(such as estrogen receptor, progesterone receptor, the p53 gene, and others) and
angiogenesis parameters (such as various proteins involved in vessel formation) will be
examined to determine their prevalence in tissue specimens and their relationship to patient
survival. When possible, the findings will be compared with non-IBC tissue samples.
Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast cancer
that disproportionately affects young women. The risk factors and pathogenesis of these
tumors are unknown and it is unclear whether tumors showing various clinical, pathological
or molecular features behave differently. IBC appears to be a highly angiogenic tumor. In
this study, tumor markers and parameters of angiogenesis will be further investigated in
The Inflammatory Breast Cancer Registry and Biospecimen Repository is a project funded by a
grant from the Department of Defense to Paul H. Levine at GWUMC. The purpose of the registry
is to develop a national registry of patients with IBC that will contain standardized
clinical, epidemiological, and pathological information, along with recurrence and survival
data. The goal is to obtain specimens from approximately 150 patients with IBC. The data in
the registry and repository will be made available to researchers to aid in the development
of a clinicopathological diagnosis of IBC. Investigators at GWUMC will consent recruited
patients and collect clinical data. Subjects will not be recruited, evaluated, or monitored
at the NCI. The GWUMC IRB will oversee human subjects protection issues. All samples
obtained from GWUMC will be blinded and coded to the NCI investigators. In addition to the
samples from George Washington University, we will obtain 150 control samples from the
National Cancer Institute Cooperative Breast Cancer Tissue Resource. These samples were not
available when this protocol was first submitted.
In collaboration with George Washington University Medical Center (GWUMC), we plan to test
tissue specimens collected in the IBC registry and biospecimen repository. We will obtain
frozen tissue (tissue and/or normal) and paraffin-embedded tissue blocks from each case.
Genetic testing will not be performed on any of the samples. One pathologist reviews cases
for grade and lymphovascular invasion (LVI) based on H& E staining. Specimens will be tested
for biological markers associated with IBC to help in classification of these tumors. These
include ER, E-cadherin, podoplanin, ReIB, RhoC and vasodilator-stimulated phosphoprotein
(VASP). Angiogenesis parameters will also be evaluated. These include hypoxia-inducible
factor 1 alpha (HIF-1 alpha), vascular endothelial growth factor D (VEGF-D) protein
expression, VEGF-C protein expression, VEGF-receptor 2 (VEGFR-2, Kdr) or VEGF-receptor 3
- INCLUSION CRITERIA:
Patients with inflammatory breast cancer.
Age greater than 18 years.