Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

Running, not enrolling · Phase 3

Conditions studied: Breast Screening

In brief

This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

Key facts

Study ID

NCT03233191

Run by

ECOG-ACRIN Cancer Research Group

People needed

108508

Starts

2017-09-28

Expected to finish

2030-12-31

Last updated by the study team

2026-07-10

Who can join

Age: 45 and older, up to 74. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women of childbearing potential must not be known to be pregnant or lactating
• Patients must be scheduled for, or have intent to schedule, a screening mammogram
• Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol.
• Patients must be willing and able to provide a written informed consent
• Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) warranting a diagnostic rather than a screening mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are eligible as long as other criteria are met
• Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
• Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
• Patients must not have breast enhancements (e.g., implants or injections)
• ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
• To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above:
• Patients are pre-menopausal; OR
• Post-menopausal aged 45-69 with any of the following three risks factors:
• Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
• Family history of breast cancer (first degree relative with breast cancer), or, positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, or
• Currently on hormone therapy; OR
• Post-menopausal ages 70-74 with either of the following two risk factors:
• Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
• Currently on hormone therapy
• Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry; for the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to hysterectomy and oophorectomy will be considered postmenopausal; women who no longer have menses due to hysterectomy without oophorectomy will be considered premenopausal until age 52 and postmenopausal thereafter
• All other postmenopausal women are eligible for inclusion in the biennial screening regimen
• For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy AND have not had a prior mammogram, breast density will be determined by the radiologist?s recording of it at the time of interpretation of the first study screening examination, either DM or TM; for those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic DM portion of the TM examination; such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than 1% of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) population
• Breast density will be determined by prior mammography reports, when available; all other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report

Where it is running

• Mobile Infirmary Medical Center — Mobile, Alabama, United States
• Banner-University Medical Center Phoenix — Phoenix, Arizona, United States
• University of Arizona College of Medicine Phoenix — Phoenix, Arizona, United States
• Valleywise Comprehensive Health Center - Phoenix — Phoenix, Arizona, United States
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States
• Scottsdale Medical Imaging Limited — Scottsdale, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kern Radiology Medical Group Inc — Bakersfield, California, United States
• Los Angeles General Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Kaiser Permanente-Modesto — Modesto, California, United States
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States
• UCHealth University of Colorado Hospital — Aurora, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• The Women's Imaging Center — Denver, Colorado, United States
• Radiology Imaging Associates — Englewood, Colorado, United States
• UCHealth Highlands Ranch Hospital — Highlands Ranch, Colorado, United States
• UCHealth Lone Tree Health Center — Lone Tree, Colorado, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Florida Health Science Center - Jacksonville — Jacksonville, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Northeast Georgia Medical Center Braselton — Braselton, Georgia, United States
• Lewis Cancer and Research Pavilion at Saint Joseph's/Candler — Savannah, Georgia, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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