Massive trial tests if 3D mammograms beat 2D for breast cancer detection

NCT ID NCT03233191

Prevention Sponsor: ECOG-ACRIN Cancer Research Group Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This phase 3 trial is comparing two types of mammograms—standard 2D digital mammography and newer 3D tomosynthesis—to see which is better at finding advanced breast cancers early. Over 108,000 women are taking part, and researchers will track cancer diagnoses over 4.5 years. The goal is to reduce the number of advanced cancers found and the need for extra imaging or treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Digital tomosynthesis mammography (3D mammogram) compared to standard digital mammography (2D mammogram)
What this could lead to: If 3D mammograms prove better at catching advanced breast cancers early, this could become the new standard for breast cancer screening, reducing the need for extra tests and treatments.
What could go wrong: This is a large, late-stage trial, but results may show only a small benefit or no difference between the two methods. Also, 3D mammography exposes women to slightly more radiation, though still within safe limits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 108,508 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2017

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 74 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast screening

Contacts and locations

Locations

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States
Arnot Ogden Medical Center/Falck Cancer Center

Elmira, New York, 14905, United States
Aultman Health Foundation

Canton, Ohio, 44710, United States
BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada
Banner-University Medical Center Phoenix

Phoenix, Arizona, 85006, United States
Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States
Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States
Baptist Memorial Hospital for Women

Memphis, Tennessee, 38120, United States
Bon Secours Westchester Emergency Center

Midlothian, Virginia, 23113, United States
Boston Medical Center

Boston, Massachusetts, 02118, United States
Bromenn Lifecare Center

Bloomington, Illinois, 61701, United States
Bromenn Regional Medical Center

Normal, Illinois, 61761, United States
Bronson Battle Creek

Battle Creek, Michigan, 49017, United States
CERIM

Buenos Aires, 1425, Argentina
CHU de Quebec-Hopital du Saint-Sacrement (HSS)

Québec, Quebec, G1S 4L8, Canada
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Hoopeston Regional Health Center

Hoopeston, Illinois, 60942, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle at The Riverfront

Danville, Illinois, 61832, United States
Carle on Fairchild

Danville, Illinois, 61832, United States
Carson Tahoe Regional Medical Center

Carson City, Nevada, 89703, United States
Chiang Mai University

Chiang Mai, Muang, 50200, Thailand
Cleveland Clinic Cancer Center Beachwood

Beachwood, Ohio, 44122, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Easton Hospital

Easton, Pennsylvania, 18042, United States
Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin, 54880, United States
Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States
Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States
Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States
Helen F Graham Cancer Center

Newark, Delaware, 19713, United States
Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States
Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada
Hospital Sotero Del Rio

Puente Alto, Santiago Metropolitan, 8207257, Chile
Hunterdon Medical Center

Flemington, New Jersey, 08822, United States
Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States
John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States
Kaiser Permanente - Kensington Medical Center

Kensington, Maryland, 20895, United States
Kaiser Permanente-Modesto

Modesto, California, 95356, United States
Kern Radiology Medical Group Inc

Bakersfield, California, 93306, United States
LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States
Los Angeles General Medical Center

Los Angeles, California, 90033, United States
M D Anderson Cancer Center

Houston, Texas, 77030, United States
MUSC Health East Cooper

Mt. Pleasant, South Carolina, 29464, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States
Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States
Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States
MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Memorial Hermann Imaging Center - Upper Kirby

Houston, Texas, 77098, United States
Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States
Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States
Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital

The Bronx, New York, 10461, United States
Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States
NYP/Weill Cornell Medical Center

New York, New York, 10065, United States
National Cancer Center-Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea
Northeast Georgia Medical Center Braselton

Braselton, Georgia, 30517, United States
Northside Hospital

Atlanta, Georgia, 30342, United States
Northwest Cancer Center - Valparaiso

Valparaiso, Indiana, 46383, United States
Ochsner LSU Health Saint Mary's Medical Center

Shreveport, Louisiana, 71101, United States
Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Oncosalud S.A.C.

Lima, Lima 41, Peru
Ospedale Ca Foncello di Treviso - ULSS 2 Marca Trevigiana

Treviso, 31100, Italy
Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, K1H 8L6, Canada
Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky, 42303, United States
Parc Tauli Sabadell Hospital Universitari

Sabadell, Barcelona, 08208, Spain
Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States
Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States
Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States
Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States
Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States
Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States
ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States
ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States
Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Radiology Imaging Associates

Englewood, Colorado, 80112, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Riverview Medical Center/Booker Cancer Center

Red Bank, New Jersey, 07701, United States
Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States
Saint Joseph's Health Care London

London, Ontario, N6A 4V2, Canada
Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States
Saint Mary Medical Center

Hobart, Indiana, 46342, United States
Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States
San Juan City Hospital

San Juan, 00936, Puerto Rico
Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States
Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, 56701, United States
Scottsdale Medical Imaging Limited

Scottsdale, Arizona, 85258, United States
Sentara Leigh Hospital

Norfolk, Virginia, 23502, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
Sentara Princess Anne Hospital

Virginia Beach, Virginia, 23456, United States
Sidney Kimmel Cancer Center Washington Township

Sewell, New Jersey, 08080, United States
Southpointe-Sanford Medical Center Fargo

Fargo, North Dakota, 58103, United States
Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States
Spartanburg Medical Center - Mary Black Campus

Spartanburg, South Carolina, 29307, United States
Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States
Taipei Veterans General Hospital

Taipai, 112, Taiwan
The Community Hospital

Munster, Indiana, 46321, United States
The Women's Imaging Center

Denver, Colorado, 80209, United States
ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States
Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States
UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129, United States
UCHealth Lone Tree Health Center

Lone Tree, Colorado, 80124, United States
UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States
UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States
University Hospital

San Antonio, Texas, 78229, United States
University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States
University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States
University of Arizona College of Medicine Phoenix

Phoenix, Arizona, 85006, United States
University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States
University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States
University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States
University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States
University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States
University of North Carolina-Hillsborough Campus

Hillsborough, North Carolina, 27278, United States
University of Rochester

Rochester, New York, 14642, United States
University of Tennessee - Knoxville

Knoxville, Tennessee, 37920, United States
University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States
University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States
Valleywise Comprehensive Health Center - Phoenix

Phoenix, Arizona, 85008, United States
Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, 37204, United States
Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States
West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States
West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States
Wexford Health and Wellness Pavilion

Wexford, Pennsylvania, 15090, United States
Woman's Hospital

Baton Rouge, Louisiana, 70817, United States
Women's Diagnostic Center - Munster

Munster, Indiana, 46321, United States
Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

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