Surveillance Imaging Modalities for Breast Cancer Assessment

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36444 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-11-30

Brief Summary

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The purpose of this study is to determine the effectiveness of surveillance breast MRI compared to mammography alone in women with a personal history of breast cancer

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Detailed Description

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Our overall aim is to find out how well MRI works compared with mammography for surveillance in women who have previously had breast cancer. Specifically, our goals are to:

1. Understand doctors' and patients' experiences with surveillance mammography and MRI
2. Provide evidence on which outcomes are more or less likely to occur
3. Develop patient decision aids to help women and their doctors choose the surveillance method that is right for them

How we will conduct the study: We will work with patients, doctors, policy makers, advocacy groups, and researchers to improve surveillance for women who have a personal history of breast cancer. Through focus groups with patients and interviews with doctors, we will gain insights into women's experience with surveillance mammography and MRI. We will also compare mammography to MRI using data from the Breast Cancer Surveillance Consortium-the largest collection of breast cancer surveillance data in the nation. We will use data from more than 13,000 women diagnosed with breast cancer between 2005 and 2012 to determine how well each test works. We will measure the tests' effectiveness at finding second cancers, and estimate the likelihood of different outcomes. We will also determine whether one test appears to work better than the other to detect second breast cancers among different groups of women. We will then develop patient decision aids to help women and their doctors make more-informed choices about surveillance.

What we hope to achieve: We hope this study will improve medical decision making and care for the 3 million women in the United States who have a history of breast cancer. Specifically, our results will help women and their doctors make clearer, better choices about the surveillance method that is right for them.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Mammograms

Surveillance mammograms in women with a personal history of breast cancer

No interventions assigned to this group

Breast MRI

Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Women with a diagnosis of lobular carcinoma in situ
* Women with missing cancer staging data from Surveillance, Epidemiology and End Results (SEER) Program records
* Women with Stage 4 breast cancer at time of diagnosis
* Women with a diagnosis of a second breast cancer event within six months of the primary diagnosis
* Women who die within six months of primary diagnosis
* Women who have had a double mastectomy

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No