Program Testing Early Cancer Treatment and Screening (PROTECTS)

The PROTECTS Project is comprised of two sub-studies. One of these sub-studies, described below, addresses whether breast cancer screening before the age of 50 is efficacious, and examines the efficacy stratified by average or increased breast cancer risk. The other sub-study examines the use of prophylactic mastectomy in a defined population.

Early Screening Sub-study

Background

A dearth of data exists to support current breast cancer screening recommendations for women ages 40-49 according to the level of risk for breast cancer. Women at increased risk may benefit differentially compared with women at average risk. . This study seeks to examine whether mammography and/or clinical breast examination between the ages of 40-49 influenced breast cancer mortality according to the level of risk.

Study Aim

The primary aim of this study is to evaluate whether breast cancer screening with mammography and/or clinical breast examination reduces breast cancer mortality among women in two age cohorts (40-49; 50-65) and at average or increased breast cancer risk because of a family history of breast cancer or personal history of breast biopsy.

Methods

Using a case-control design, the project team retrospectively ascertained 1,351 cases of breast cancer occurring at six health plans between 1983 and 1993, and 2,501 matched controls. Chart abstraction was used to collect data about personal and family history, screening patterns, characteristics of breast cancer, previous breast procedures, and other medical conditions. Cases were matched to eligible controls on health plan, age and breast cancer risk level.

Significance

It is important to determine the efficacy of preventive strategies for women, such as early breast cancer screening by clinical breast examination and mammography. Because randomized controlled trials are unlikely and prospective studies would take many years of follow-up, retrospective studies of practices with very large populations and computerized medical records can provide important information for the clinical care of women at varying ages and risk of breast cancer, by determining the efficacy of this screening strategy.

Project Status

This project was funded as part of the CRN's initial four-year funding cycle. The project leader for the PROTECTS project is Suzanne Fletcher, MD, MSc. This sub-project was led by Joann Elmore, MD, MPH. Analyses are continuing. The CRN Bibliography includes a publication on the rigorous approaches to training and quality assurance used by the study team. The main study manuscript is currently being drafted for submission to a leading medical journal.

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