Purpose of the Breast Imaging Study

Purpose of Study

The purpose of the "Breast Imaging Study in Women at High Genetic Risk of Breast Cancer" (NCI Protocol Number 01-C-0009) is to:

Evaluate the newest breast screening procedures to see if they are effective in finding cancer early, especially in younger women

Develop new tools to assist in finding malignant or pre-malignant changes in breast cells, before cancer can be detected clinically

Examine how women live and cope with a high risk of breast and ovarian cancer

The study focuses on pre-menopausal women between the ages of 25 and 56, who have undergone genetic testing and have found that they have an altered ("mutated") BReast CAncer 1 (BRCA1) or BReast CAncer 2 (BRCA2) gene. These women are aware of their increased genetic risk of breast cancer and, most likely, have had varying degrees of interaction with a health care professional about their increased risk and cancer surveillance options.

The study will explore various screening methods for early detection of breast and ovarian cancer in these high-risk women. It will also try to determine if breast tissue characteristics in women with these mutations differ from those in women with a normal gene.

Screening methods include:

routine clinical examination of the breasts and ovaries
mammogram
instruction in breast self-examination technique
CA-125 blood test
transvaginal ultrasound of the ovaries
magnetic resonance imaging (MRI) of the breasts
breast duct lavage
positron emission tomography (PET) scan of the breasts and ovaries (in certain cases)

Study participants will be seen annually at the NIH Clinical Center for four years.

If are a woman between 25 and 56 years of age, and know that you have a mutation in either the BRCA1 or BRCA2 genes, or if you have not been tested but have a parent, sibling (brother or sister) or child who has a mutation, NCI invites you to contact us about joining the study. We hope to learn more about how to find early breast cancers in women with these genetic mutations.

NCI is also conducting a study of ovarian cancer risk-reducing surgery and screening in women at high genetic risk (NCI Protocol Number 02-C-0268 "Prospective Study of Risk-Reducing Salpingo-Oophorectomy and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer"). Participants in the Breast Imaging study may be eligible to participate in the ovarian cancer study as well, if they wish.