Trial Outcomes & Findings for Surveillance Imaging Modalities for Breast Cancer Assessment (NCT NCT02212834)

NCT ID: NCT02212834

Last Updated: 2024-08-22

Results Overview

Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI

• Recruitment status: COMPLETED
• Target enrollment: 36444 participants
• Primary outcome timeframe: 12 months post surveillance exam
• Results posted on: 2024-08-22

Participant Flow

Cohort analysis of women with one or more observed breast cancer surveillance exams and primary cancer diagnosis between 2003 and 2012

Not a clinical trial. Analyses were conducted with the entire population who met study criteria. Unit of analysis was surveillance exam.

Unit of analysis: exams

Participant milestones

Measure	Mammograms Surveillance mammograms in women with a personal history of breast cancer	Breast MRI Surveillance Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
Overall Study STARTED	33938 33,938	2506 2,506
Overall Study COMPLETED	33938 33,938	2506 2,506
Overall Study NOT COMPLETED	0 NA	0 NA

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surveillance Imaging Modalities for Breast Cancer Assessment

Baseline characteristics by cohort

Measure	Mammograms n=33938 surveillance exams Surveillance mammograms in women with a personal history of breast cancer	Breast MRI n=2506 surveillance exams Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer	Total n=36444 surveillance exams Total of all reporting groups
Age, Customized Age at exam · 18 - 39 years	388 surveillance exams n=33938 surveillance exams	153 surveillance exams n=2506 surveillance exams	541 surveillance exams n=36444 surveillance exams
Age, Customized Age at exam · 40 - 49 years	3,635 surveillance exams n=33938 surveillance exams	574 surveillance exams n=2506 surveillance exams	4209 surveillance exams n=36444 surveillance exams
Age, Customized Age at exam · 50 - 59 years	8,626 surveillance exams n=33938 surveillance exams	1,005 surveillance exams n=2506 surveillance exams	9631 surveillance exams n=36444 surveillance exams
Age, Customized Age at exam · 60 - 69 years	9,852 surveillance exams n=33938 surveillance exams	632 surveillance exams n=2506 surveillance exams	10484 surveillance exams n=36444 surveillance exams
Age, Customized Age at exam · 70 - 79 years	7,167 surveillance exams n=33938 surveillance exams	133 surveillance exams n=2506 surveillance exams	7300 surveillance exams n=36444 surveillance exams
Age, Customized Age at exam · > or = 80 years	4,270 surveillance exams n=33938 surveillance exams	9 surveillance exams n=2506 surveillance exams	4279 surveillance exams n=36444 surveillance exams
Sex: Female, Male Female	33,938 surveillance exams n=33938 surveillance exams	2,506 surveillance exams n=2506 surveillance exams	36444 surveillance exams n=36444 surveillance exams
Sex: Female, Male Male	0 surveillance exams n=33938 surveillance exams	0 surveillance exams n=2506 surveillance exams	0 surveillance exams n=36444 surveillance exams
Race/Ethnicity, Customized Race/ethnicity at time of exam · White, non-hispanic	26,717 surveillance exams n=33938 surveillance exams	2,069 surveillance exams n=2506 surveillance exams	28786 surveillance exams n=36444 surveillance exams
Race/Ethnicity, Customized Race/ethnicity at time of exam · Black, non-hispanic	2,862 surveillance exams n=33938 surveillance exams	62 surveillance exams n=2506 surveillance exams	2924 surveillance exams n=36444 surveillance exams
Race/Ethnicity, Customized Race/ethnicity at time of exam · Hispanic	1,042 surveillance exams n=33938 surveillance exams	67 surveillance exams n=2506 surveillance exams	1109 surveillance exams n=36444 surveillance exams
Race/Ethnicity, Customized Race/ethnicity at time of exam · Asian or Pacific Islander	2,583 surveillance exams n=33938 surveillance exams	219 surveillance exams n=2506 surveillance exams	2802 surveillance exams n=36444 surveillance exams
Race/Ethnicity, Customized Race/ethnicity at time of exam · Mixed or Other	657 surveillance exams n=33938 surveillance exams	88 surveillance exams n=2506 surveillance exams	745 surveillance exams n=36444 surveillance exams
Race/Ethnicity, Customized Race/ethnicity at time of exam · Missing	77 surveillance exams n=33938 surveillance exams	1 surveillance exams n=2506 surveillance exams	78 surveillance exams n=36444 surveillance exams

PRIMARY outcome

Timeframe: 12 months post surveillance exam

Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI

Outcome measures

Measure	Mammograms n=33938 exams Surveillance mammograms in women with a personal history of breast cancer	Breast MRI n=2506 exams Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
Number of Breast Cancers Detected	279 cancers detected	27 cancers detected

Adverse Events

Mammograms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Breast MRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen J. Wernli, PhD

Group Health Research Institute

Phone: 206-287-2934

Email: wernli.k@ghc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place