Surveillance Imaging Modalities for Breast Cancer Assessment

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02212834
• Lead Sponsor: Kaiser Permanente

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-08
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2016-11-28
• Results First Submitted QC: 2016-12-13
• Results First Posted: 2017-02-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36444

Inclusion Criteria

Surveillance imaging exams in women included in the Breast Cancer Surveillance Consortium who are 18+ years of age at the the of a Stage 0-III incident breast cancer diagnosis between January 1, 2005 and December 31, 2012.

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Breast Cancers Detected	12 months post surveillance exam	Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI