Markers for Predicting Risk of Breast Cancer in Women of Different Races

Evidence suggests that, besides reduced access to care, the increase in breast cancer
incidence and mortality in AA (African American) compared to EA (European American or
Caucasian) women is influenced by the biology of the tumor. Gene methylation changes caused
by environmental factors starting at birth is one mechanism through which genetic and
non-genetic factors could affect development of breast cancer and which could underlie
disparities in aggressiveness. The investigators were the first to show that a panel of genes
was hypermethylated specifically in AA-ER-negative tumors in young women in comparison to
EA-tumors in women of the same age. Gene promoter methylation is found at low levels in
healthy breast tissues from women without cancer. Race and family history of cancer increase
the likelihood of these early events. Thus, epigenetic changes may be early events in
transformation of breast cells and tumor formation.

This study will enroll women from different ethnic backgrounds undergoing mastectomy in order
to collect normal and tumor tissue to study these genetic changes and breast cancer risk.

Inclusion Criteria:

- Women

- 18 years and older

- Histologically proven infiltrating carcinoma of the breast on diagnostic biopsy. NOTE:
Individuals planning bilateral mastectomy procedures (for either bilateral cancers or
contralateral prophylactic procedures) either at the same time or in the future will
be asked to have tissue removed for the study from both breasts.

- ER-negative, any PR status, and any HER2 status (i.e., ER-, PR any, HER2- or ER-, PR
any, HER2+; "triple positive" breast cancers are not eligible).

- Unresected, untreated breast cancer planning surgical management with mastectomy (with
or without axillary nodal evaluation/dissection and/or with any other clinical
assessment).

- Willing and able to sign an informed consent form

Exclusion Criteria: