Trial Information

Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia

Breast cancer characterized by diffuse erythema and edema, or peau d'orange, of the breast
(inflammatory breast cancer (IBC)) is rare, particularly aggressive, and poorly understood.
The extent of redness and edema or peau d'orange, of the breast required for a diagnosis of
IBC has not been standardized. According to the most recent American Joint Committee on
Cancer (AJCC) definition of inflammatory breast cancer, the signs of redness and edema or
peau d'orange, should cover the majority of the breast, and should have arisen quickly.
Breast cancers with redness and edema or peau d'orange, account for approximately 4 percent
of breast cancers in the United States, but up to 23 percent of breast cancers in Egypt and
Tunisia.

The proposed pilot study will determine the feasibility of conducting a case-control study
of inflammatory breast cancer in collaboration with the National Cancer Institute-Cairo,
Egypt, and the Institut Salah Azaiz, Tunis, Tunisia, the major cancer centers in Egypt and
Tunisia, and Cairo University Hospital and Charles Nicolle Hospital, affiliated general
hospitals from which controls will be selected. Currently, neither case study hospital
collects data on the number of inflammatory breast cancer cases meeting the AJCC definition
which will be used for the proposed case-control study. In addition, the geographic
distribution of IBC cases at the two study hospitals (knowledge of which is necessary for
the selection of appropriate controls) is unknown.

The goals of the pilot study are to assess the feasibility of the following critical
components of the case-control study: 1) identifying a sufficient number of IBC cases at the
time of diagnosis in the two study hospitals; 2) selecting appropriate hospital-based
control subjects; 3) collecting frozen pre-treatment tumor tissue; 4) obtaining digital
photographs of the breasts of IBC cases; and 5) communicating and working collaboratively
with the study hospitals and personnel in Egypt and Tunisia. To accomplish these
objectives, IBC cases meeting the AJCC definition as well as cases meeting other definitions
of IBC will be identified over a one-year period at each of the two study hospitals.
Computerized records at the control hospital for the years 2000-2003 will be used to
enumerate the number of female patients with non-chronic diseases (and their age and
geographic distribution) in the Departments of Ophthalmology and Ear, Nose and Throat (ENT).
Pre-treatment frozen tumor tissue and digital photographs of the breast will be collected
from five IBC cases at each study site.