Breast Cancer
Conditions
Keywords
Breast, Cancer, Surveillance, Imaging, Comparative, Effectiveness
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.
Interventions
None listed
Sponsors
Dartmouth College
Harvard Pilgrim Health Care
University of North Carolina, Chapel Hill
University of California, San Francisco
University of Wisconsin, Madison
Patient-Centered Outcomes Research Institute
Kaiser Permanente
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Participant flow
Recruitment details
Cohort analysis of women with one or more observed breast cancer surveillance exams and primary cancer diagnosis between 2003 and 2012
Pre-assignment details
Not a clinical trial. Analyses were conducted with the entire population who met study criteria. Unit of analysis was surveillance exam.
Participants by arm
| Arm | Count |
|---|---|
| Mammograms Surveillance mammograms in women with a personal history of breast cancer | 33 |
| Mammograms Surveillance mammograms in women with a personal history of breast cancer | 33,938 |
| Breast MRI Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer | 2 |
| Breast MRI Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer | 2,506 |
| Total | 36,479 |
Baseline characteristics
| Characteristic | Mammograms | Breast MRI | Total |
|---|---|---|---|
| Age, Customized Age at exam 18 - 39 years | 388 surveillance exams | 153 surveillance exams | 541 surveillance exams |
| Age, Customized Age at exam 40 - 49 years | 3,635 surveillance exams | 574 surveillance exams | 4209 surveillance exams |
| Age, Customized Age at exam 50 - 59 years | 8,626 surveillance exams | 1,005 surveillance exams | 9631 surveillance exams |
| Age, Customized Age at exam 60 - 69 years | 9,852 surveillance exams | 632 surveillance exams | 10484 surveillance exams |
| Age, Customized Age at exam 70 - 79 years | 7,167 surveillance exams | 133 surveillance exams | 7300 surveillance exams |
| Age, Customized Age at exam > or = 80 years | 4,270 surveillance exams | 9 surveillance exams | 4279 surveillance exams |
| Race/Ethnicity, Customized Race/ethnicity at time of exam Asian or Pacific Islander | 2,583 surveillance exams | 219 surveillance exams | 2802 surveillance exams |
| Race/Ethnicity, Customized Race/ethnicity at time of exam Black, non-hispanic | 2,862 surveillance exams | 62 surveillance exams | 2924 surveillance exams |
| Race/Ethnicity, Customized Race/ethnicity at time of exam Hispanic | 1,042 surveillance exams | 67 surveillance exams | 1109 surveillance exams |
| Race/Ethnicity, Customized Race/ethnicity at time of exam Missing | 77 surveillance exams | 1 surveillance exams | 78 surveillance exams |
| Race/Ethnicity, Customized Race/ethnicity at time of exam Mixed or Other | 657 surveillance exams | 88 surveillance exams | 745 surveillance exams |
| Race/Ethnicity, Customized Race/ethnicity at time of exam White, non-hispanic | 26,717 surveillance exams | 2,069 surveillance exams | 28786 surveillance exams |
| Sex: Female, Male Female | 33,938 surveillance exams | 2,506 surveillance exams | 36444 surveillance exams |
| Sex: Female, Male Male | 0 surveillance exams | 0 surveillance exams | 0 surveillance exams |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Breast Cancers Detected
Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI
Time frame: 12 months post surveillance exam
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mammograms | Number of Breast Cancers Detected | 279 cancers detected |
| Breast MRI | Number of Breast Cancers Detected | 27 cancers detected |