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Breast Radiology Evaluation and Study of Tissues (Breast) Stamp Project

40 Years
65 Years
Open (Enrolling)
Cancer, Breast, Neoplasms

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Trial Information

Breast Radiology Evaluation and Study of Tissues (Breast) Stamp Project

High breast density and aging are the strongest risk factors for sporadic breast cancer
among women. Although glandular epithelium contributes to mammographic density,
non-epithelial tissue components represent its major determinants: adipose tissue is
radiolucent and fibrous tissue is dense. The hypothesis is that epidemiologic factors
associated with elevated breast density alter the breast microenvironment (ME) (defined as
all cells and structures surrounding luminal glandular cells including: myoepithelial cells;
basement membrane, stromal fibroblast and myofibroblasts; endothelial cells and pericytes;
inflammatory cells, collagens, matrix proteins, growth factors, hormones, and other
biochemical components) in a manner that enhances dysregulated proliferation of breast
epithelium and ultimately cancer. Specifically, the Investigators propose that epidemiologic
factors that lead to increased exposure to hormones and inflammatory mediators alter the ME,
leading to both increased breast density and cancer. The critical importance of the ME in
carcinogenesis is supported by experimental and clinical data showing that epithelial
abnormalities alone are generally insufficient for cancer development without concurrent
changes in the ME.

The primary aim of this pilot study is to demonstrate the feasibility of collecting the
data needed to elucidate the biologic mechanisms that mediate the substantial breast cancer
risk associated with high mammographic density. Specifically, the Investigators will
develop, fine tune, and validate a complex cross-sectional study protocol to collect risk
factor data and biological specimens (blood, buccal cells, tissue fluids, and tissue)
required to discover mechanisms and biomarkers that link high mammographic density (as
measured quantitatively using computerized methods) to breast cancer risk. They will enroll
250 women between the ages of 40 to 65 years undergoing a radiologically guided biopsy at
the University of Vermont, the largest center within the Vermont Breast Cancer Surveillance
System (VBCSS), to participate in this pilot study of mammographic density.

Inclusion Criteria


Inclusion criteria for participation in the study are women, ages 40-65 years of age, who
are undergoing a radiologically-guided biopsy (stereotactic- ultrasound-guided). We will
NOT exclude subjects for current or past use of exogenous hormones; prior hysterectomy or
salpingoophorectomy or presentation with a breast mass. Although most biopsies are
prompted by a radiologic finding (typically abnormal calcifications or masses), some
biopsies are performed for symptoms that are unassociated with a radiologic finding, such
as nipple discharge, palpable mass, discomfort, etc. Elevated density per se is not a
biopsy indication. ALL women referred for radiologically guided biopsy, irrespective of
the indication, will be considered eligible for the pilot study.


We will EXCLUDE women who have a prior history of breast cancer, have had an EXCISIONAL
breast biopsy within one year, women who have implants in place, women taking tamoxifen or
raloxifene for chemoprevention and women who have received non-surgical treatments for
cancers of other organs.

Type of Study:


Study Design:


Principal Investigator

Gretchen Gierach, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

May 2007

Completion Date:

Related Keywords:

  • Cancer
  • Breast, Neoplasms
  • Breast
  • Radiology
  • Pathology
  • Microenvironment
  • Harmones
  • Neoplasms



University Of Vermont Burlington,, Vermont  05403