Trial Outcomes & Findings for Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT (NCT NCT02643966)

NCT ID: NCT02643966

Last Updated: 2023-06-29

Results Overview

Results from the first radiologist observer are presented

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6266 participants
• Primary outcome timeframe: 3 Years
• Results posted on: 2023-06-29

Participant Flow

Participant milestones

Measure	Whole Breast Ultrasound All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists Whole breast ultrasound: Breast cancer screening with whole breast ultrasound
First Screening Round STARTED	6266
First Screening Round COMPLETED	6178
First Screening Round NOT COMPLETED	88
Between First and Second Screening STARTED	6178
Between First and Second Screening COMPLETED	6020
Between First and Second Screening NOT COMPLETED	158
Second Screening Round STARTED	6020
Second Screening Round COMPLETED	5937
Second Screening Round NOT COMPLETED	83
Between Second and Third Screening STARTED	5937
Between Second and Third Screening COMPLETED	5680
Between Second and Third Screening NOT COMPLETED	257
Third Screening Round STARTED	5680
Third Screening Round COMPLETED	5437
Third Screening Round NOT COMPLETED	243

Reasons for withdrawal

Measure	Whole Breast Ultrasound All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists Whole breast ultrasound: Breast cancer screening with whole breast ultrasound
First Screening Round ineligible	1
First Screening Round excluded from analysis	2
First Screening Round Lost to Follow-up	56
First Screening Round Withdrawal by Subject	28
First Screening Round Death	1
Between First and Second Screening Lost to Follow-up	65
Between First and Second Screening Withdrawal by Subject	82
Between First and Second Screening women who skipped year 2 exam	11
Second Screening Round Withdrawal by Subject	20
Second Screening Round Lost to Follow-up	57
Second Screening Round Physician Decision	2
Second Screening Round Death	4
Between Second and Third Screening Lost to Follow-up	75
Between Second and Third Screening Death	1
Between Second and Third Screening Withdrawal by Subject	181
Third Screening Round PI excluded	2
Third Screening Round Lost to Follow-up	241

Baseline Characteristics

Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT

Baseline characteristics by cohort

Measure	Whole Breast Ultrasound n=6179 Participants All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists Whole breast ultrasound: Breast cancer screening with whole breast ultrasound
Age, Continuous	54.8 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	6179 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6160 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	49 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	106 Participants n=5 Participants
Race (NIH/OMB) White	5991 Participants n=5 Participants
Race (NIH/OMB) More than one race	29 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6179 Participants n=5 Participants
Breast Density scattered	203 Participants n=5 Participants
Breast Density heterogeneously dense	4989 Participants n=5 Participants
Breast Density extremely dense	987 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Years

Population: Screens 2 \& 3 include women who were analyzable after the end of Screening Round 2

Results from the first radiologist observer are presented

Outcome measures

Measure	Digital Breast Tomosynthesis (DBT) n=6178 Participants All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT alone.	DBT and WBUS n=6178 Participants All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT+WBUS.	WBUS Only All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the number of cancers detected by first observer for WBUS alone.
Cancer Yield Per 1,000 Screen 1	5.0 Cancer yield per 1,000 Interval 3.4 to 7.1	6.3 Cancer yield per 1,000 Interval 4.5 to 8.6	—
Cancer Yield Per 1,000 Screens 2 & 3	4.9 Cancer yield per 1,000 Interval 4.0 to 5.9	5.9 Cancer yield per 1,000 Interval 4.9 to 6.9	—

PRIMARY outcome

Timeframe: 3 years

Population: Women diagnosed with cancer

DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer

Outcome measures

Measure	Digital Breast Tomosynthesis (DBT) n=6178 Participants All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT alone.	DBT and WBUS n=6178 Participants All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT+WBUS.	WBUS Only All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the number of cancers detected by first observer for WBUS alone.
Sensitivity (True Positive Rate) Year/Screen 1	68.9 percentage of participants with cancer Interval 53.4 to 81.8	86.7 percentage of participants with cancer Interval 73.2 to 95.0	—
Sensitivity (True Positive Rate) Years/Screens 2 & 3	69.1 percentage of participants with cancer Interval 57.9 to 78.9	82.7 percentage of participants with cancer Interval 72.7 to 90.2	—

PRIMARY outcome

Timeframe: 3 years

Population: Women who did not have a cancer diagnosis

DBT false-positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer

Outcome measures

Measure	Digital Breast Tomosynthesis (DBT) n=6178 Participants All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT alone.	DBT and WBUS n=6178 Participants All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT+WBUS.	WBUS Only All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the number of cancers detected by first observer for WBUS alone.
False-positive Recall Rate Year/Screen 1	7.0 percent of participants without cancer Interval 6.4 to 7.7	11.5 percent of participants without cancer Interval 10.7 to 12.3	—
False-positive Recall Rate Years/Screens 2 & 3	5.9 percent of participants without cancer Interval 5.5 to 6.4	9.7 percent of participants without cancer Interval 9.1 to 10.2	—

SECONDARY outcome

Timeframe: 3 years

Population: Cancers detected by first observer for all 3 Screenings/Years combined

Counts and percentages of participants diagnosed with cancer and detected by first observer with DBT only, DBT and WBUS, and WBUS only

Outcome measures

Measure	Digital Breast Tomosynthesis (DBT) n=17552 Participants All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT alone.	DBT and WBUS n=17552 Participants All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT+WBUS.	WBUS Only n=17552 Participants All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the number of cancers detected by first observer for WBUS alone.
Types of Abnormalities Detected by Ultrasound and Tomosynthesis No. of invasive cancers	32 Participants	31 Participants	16 Participants
Types of Abnormalities Detected by Ultrasound and Tomosynthesis No. of Cancers	55 Participants	32 Participants	19 Participants
Types of Abnormalities Detected by Ultrasound and Tomosynthesis No. of Node-positive among available staging	3 Participants	5 Participants	3 Participants

Adverse Events

Whole Breast Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wendie A. Berg

University of Pittsburgh

Phone: 412-641-1635

Email: bergwa@upmc.edu

Results disclosure agreements

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