Program Testing Early Cancer Treatment and Screening (PROTECTS)

The PROTECTS Project is comprised of two sub-studies. One of these sub-studies, described below, examines the use of prophylactic mastectomy in a defined population. The second sub-study addresses whether mammography screening prior to age 50 is appropriate for women at increased risk of breast cancer.

Prophylactic Mastectomy Sub-study

Background

It is important to determine the efficacy of preventive strategies such as prophylactic mastectomy for women at increased risk for breast cancer. Risk is higher for women with certain characteristics. Women whose risk of developing breast cancer is more than twice that of women in the general population include those with a family history of breast cancer, a personal history of previous unilateral breast cancer, and benign histologic breast abnormalities A personal history of breast cancer also confers increased risk of a new primary case of breast cancer in the contralateral breast after treatment of the original cancer.

Study Aim

The overall goal of this project is to determine whether prophylactic mastectomy reduces the risk of subsequent breast cancer in women at increased risk of breast cancer because of a family history of breast cancer, a personal history of unilateral breast cancer or ovarian cancer, or certain pathologic diagnoses on breast biopsy, such as atypical hyperplasia.

Methods

This retrospective study examined the efficacy of bilateral prophylactic mastectomy (BPM) when undertaken by women with one or more breast cancer risk factors, as well as the use of contralateral prophylactic mastectomy among women who had received a breast cancer diagnosis. These two groups were ascertained using the same procedures, but are being analyzed separately. The study included all women with prophylactic mastectomy and a stratified random sample of those who did not undergo prophylactic mastectomy. Medical records were reviewed to confirm eligibility and gather detailed information about risk factors and history of specified medical procedures (including cancer). Medical record data were abstracted directly into a computerized system developed specifically for this study.

Significance

With the identification of the BRCA1 and BRCA2 genes, the need to determine the efficacy of preventive strategies such as early breast cancer screening and prophylactic mastectomy has become urgent. Moreover, there are many more women at moderate than at high risk for breast cancer in the United States, and the majority of these women are cared for in community-based rather than referral practices. To date, there has been little discussion of prophylactic options for women at moderate risk for breast cancer. Additional information on the physical and psychological outcomes of prophylactic mastectomy for this group will help inform women's and clinicians' decision-making.

Project Status

This project was funded as part of the CRN's initial four-year funding cycle. The project leader is Suzanne Fletcher, MD, MSc. Analyses are continuing. The CRN Bibliography includes a publication on the computerized system used for chart abstraction.

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