Breast Cancer
EA1151 / TMIST
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
STATUS: Active
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.
- Patients must be women age 45 or older and under age 75 at the time of study entry
- 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 new symptoms or signs of benign or malignant breast disease (e.g., bloody or clear nipple discharge, breast lump) based on physician physical exam or self breast exam that have not been previously worked up with imaging; patients with physiologic nipple discharge or 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 currently have breast enhancements (e.g., implants or radiopaque 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 four risk factors: ** Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or ** At least one benign breast biopsy with a diagnosis of lobular carcinoma in situ (LCIS) or atypia of any kind (atypical ductal hyperplasia, atypical lobular hyperplasia, atypical hyperplasia not otherwise specified [NOS], or intraductal papilloma with atypia), or ** Family history of breast cancer (first degree relative with breast cancer) or family history of breast cancer is not known, or, participant 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 three risk factors: ** Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or ** At least one benign breast biopsy with a diagnosis of LCIS or atypia of any kind (atypical ductal hyperplasia, atypical lobular hyperplasia, atypical hyperplasia NOS, or intraductal papilloma with atypia), or ** Currently on hormone therapy *** For this study we define hormone therapies as those that increase breast cancer risk, including: estrogen, progesterone, estrogen/progesterone analogs, or hormonal birth control prescribed by a doctor, and include hormones in oral contraceptives, patch, gel, etc. BUT, for this study; soy use is not considered 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 bilateral oophorectomy with either hysterectomy or endometrial ablation will be considered postmenopausal; women who no longer have menses due to either hysterectomy or endometrial ablation, and who have at least one ovary 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 for whom a prior mammogram interpretation is not available, 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 2D 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, or by radiologist review of prior imaging; * NOTE: If the latter method is used, a signed, dated attestation by the radiologist indicating the resulting determination must be kept as a record and made available for monitoring/auditing * All other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report
Argentina
Buenos Aires
CERIM
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Canada
British Columbia
Vancouver
BCCA-Vancouver Cancer Centre
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Ontario
London
Saint Joseph's Health Care London
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Ottawa
Ottawa Hospital and Cancer Center-General Campus
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Toronto
Mount Sinai Hospital
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Odette Cancer Centre- Sunnybrook Health Sciences Centre
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Quebec
Montreal
Hopital Du Sacre-Coeur de Montreal
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Quebec City
CHU de Quebec-Hopital du Saint-Sacrement (HSS)
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Chile
Santiago
Puente Alto
Hospital Sotero Del Rio
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Italy
Treviso
Ospedale Ca Foncello di Treviso - ULSS 2 Marca Trevigiana
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Korea, Republic of
Gyeonggi-do
Goyang-si
National Cancer Center-Korea
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Peru
Lima
Oncosalud S.A.C.
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Spain
Barcelona
Sabadell
Parc Tauli Sabadell Hospital Universitari
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Taiwan
Taipai
Taipei Veterans General Hospital
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Thailand
Muang
Chiang Mai
Chiang Mai University
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United States
AL
Birmingham
University of Alabama at Birmingham Cancer Center
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Mobile
Mobile Infirmary Medical Center
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AR
Little Rock
University of Arkansas for Medical Sciences
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AZ
Phoenix
Banner-University Medical Center Phoenix
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Mayo Clinic Hospital in Arizona
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University of Arizona College of Medicine Phoenix
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Valleywise Comprehensive Health Center - Phoenix
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Scottsdale
Scottsdale Medical Imaging Limited
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CA
Bakersfield
Kern Radiology Medical Group Inc
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Los Angeles
Los Angeles General Medical Center
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USC / Norris Comprehensive Cancer Center
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Modesto
Kaiser Permanente-Modesto
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San Francisco
Zuckerberg San Francisco General Hospital
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CO
Aurora
UCHealth University of Colorado Hospital
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Colorado Springs
Penrose-Saint Francis Healthcare
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Denver
The Women's Imaging Center
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Englewood
Radiology Imaging Associates
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Highlands Ranch
UCHealth Highlands Ranch Hospital
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UCHealth Lone Tree Health Center
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DC
Washington
MedStar Georgetown University Hospital
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DE
Newark
Helen F Graham Cancer Center
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FL
Jacksonville
University of Florida Health Science Center - Jacksonville
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GA
Atlanta
Northside Hospital
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Braselton
Northeast Georgia Medical Center Braselton
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Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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HI
Honolulu
Queen's Medical Center
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IA
Des Moines
Mercy Medical Center - Des Moines
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Iowa City
University of Iowa/Holden Comprehensive Cancer Center
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ID
Boise
Saint Alphonsus Cancer Care Center-Boise
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Saint Luke's Cancer Institute - Boise
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IL
Bloomington
Bromenn Lifecare Center
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Chicago
John H Stroger Jr Hospital of Cook County
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Danville
Carle at The Riverfront
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Carle on Fairchild
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Decatur
Decatur Memorial Hospital
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Hoopeston
Carle Hoopeston Regional Health Center
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Mattoon
Carle Physician Group-Mattoon/Charleston
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Normal
Bromenn Regional Medical Center
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Urbana
Carle Cancer Center
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IN
Hobart
Saint Mary Medical Center
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Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
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Munster
The Community Hospital
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Women's Diagnostic Center - Munster
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Valparaiso
Northwest Cancer Center - Valparaiso
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KY
Owensboro
Owensboro Health Mitchell Memorial Cancer Center
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LA
Baton Rouge
Mary Bird Perkins Cancer Center
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Woman's Hospital
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New Orleans
Tulane University School of Medicine
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University Medical Center New Orleans
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Shreveport
LSU Health Sciences Center at Shreveport
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Ochsner LSU Health Saint Mary's Medical Center
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MA
Boston
Boston Medical Center
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Worcester
UMass Memorial Medical Center - University Campus
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MD
Kensington
Kaiser Permanente - Kensington Medical Center
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MI
Ann Arbor
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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University of Michigan Comprehensive Cancer Center
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Battle Creek
Bronson Battle Creek
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Detroit
Henry Ford Hospital
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Wayne State University/Karmanos Cancer Institute
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Farmington Hills
Weisberg Cancer Treatment Center
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Grand Rapids
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo
West Michigan Cancer Center
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West Bloomfield
Henry Ford West Bloomfield Hospital
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MN
Duluth
Essentia Health Cancer Center
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Minneapolis
Hennepin County Medical Center
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Rochester
Mayo Clinic in Rochester
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Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
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Saint Paul
Regions Hospital
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Thief River Falls
Sanford Thief River Falls Medical Center
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Virginia
Essentia Health Virginia Clinic
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MS
Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
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NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
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Durham
Duke University Medical Center
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Hillsborough
University of North Carolina-Hillsborough Campus
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Winston-Salem
Wake Forest University Health Sciences
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ND
Bismarck
Sanford Bismarck Medical Center
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Fargo
Southpointe-Sanford Medical Center Fargo
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NJ
Flemington
Hunterdon Medical Center
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New Brunswick
Saint Peter's University Hospital
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Red Bank
Riverview Medical Center/Booker Cancer Center
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Sewell
Sidney Kimmel Cancer Center Washington Township
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NM
Albuquerque
University of New Mexico Cancer Center
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NV
Carson City
Carson Tahoe Regional Medical Center
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NY
Bronx
Montefiore Medical Center-Einstein Campus
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Montefiore Medical Center-Weiler Hospital
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Elmira
Arnot Ogden Medical Center/Falck Cancer Center
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New York
Memorial Sloan Kettering Cancer Center
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NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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NYP/Weill Cornell Medical Center
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Rochester
University of Rochester
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OH
Beachwood
Cleveland Clinic Cancer Center Beachwood
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Canton
Aultman Health Foundation
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Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
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Cleveland
Cleveland Clinic Foundation
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Columbus
Ohio State University Comprehensive Cancer Center
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PA
Easton
Easton Hospital
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Hershey
Penn State Milton S Hershey Medical Center
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Philadelphia
Fox Chase Cancer Center
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Pennsylvania Hospital
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Thomas Jefferson University Hospital
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Pittsburgh
Allegheny General Hospital
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Wexford
Wexford Health and Wellness Pavilion
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PR
San Juan
San Juan City Hospital
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SC
Charleston
Medical University of South Carolina
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Columbia
Prisma Health Richland Hospital
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Greenville
Prisma Health Greenville Memorial Hospital
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Mount Pleasant
MUSC Health East Cooper
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Spartanburg
Spartanburg Medical Center
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Spartanburg Medical Center - Mary Black Campus
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TN
Knoxville
University of Tennessee - Knoxville
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Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
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Baptist Memorial Hospital for Women
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Nashville
Vanderbilt Breast Center at One Hundred Oaks
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Vanderbilt University/Ingram Cancer Center
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TX
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
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Houston
M D Anderson Cancer Center
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Memorial Hermann Imaging Center - Upper Kirby
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Memorial Hermann Texas Medical Center
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San Antonio
University Hospital
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VA
Charlottesville
University of Virginia Cancer Center
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Midlothian
Bon Secours Westchester Emergency Center
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Norfolk
Sentara Leigh Hospital
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Sentara Norfolk General Hospital
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Virginia Beach
Sentara Princess Anne Hospital
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WA
Seattle
Swedish Medical Center-First Hill
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Email: PCRC-NCORP@Swedish.org
WI
Appleton
ThedaCare Regional Cancer Center
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Email: ResearchDept@thedacare.org
La Crosse
Gundersen Lutheran Medical Center
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Email: cancerctr@gundersenhealth.org
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
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Email: clinicaltrials@cancer.wisc.edu
Marshfield
Marshfield Medical Center-Marshfield
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Email: oncology.clinical.trials@marshfieldresearch.org
Mukwonago
ProHealth D N Greenwald Center
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Email: research.institute@phci.org
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
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Superior
Essentia Health Saint Mary's Hospital - Superior
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Waukesha
UW Cancer Center at ProHealth Care
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Email: Chanda.miller@phci.org
WV
Morgantown
West Virginia University Healthcare
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Email: cancertrialsinfo@hsc.wvu.edu
PRIMARY OBJECTIVE: I. To compare the cumulative proportions of participants reaching the primary endpoint in the two study arms, using time-to-advanced cancer measured from randomization. SECONDARY OBJECTIVES: I. To assess the potential effect of age, menopausal and hormonal status, breast density, race, ethnicity and family cancer history on the primary endpoint difference between the two arms. II. To compare the diagnostic performance of tomosynthesis (TM) and digital mammography (DM), as measured by the area under the receiver operating characteristic (ROC) curve (AUC), sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). III. To compare the recall rates and biopsy rates for TM versus DM, with subset analyses by the same variables as listed in aim II. IV. To compare the rate of interval cancers for TM and DM and to assess the mechanism of diagnosis for these interval cancers with categorization by symptomatic versus (vs) asymptomatic, and how detected: diagnosed via physical examination, mammography, ultrasound (US), magnetic resonance imaging (MRI) or other technologies. V. To examine the correlation between Breast Imaging Reporting and Data System (BIRADS) imaging features and histologic and genetic features, such as invasive ductal and invasive lobular histology, high grade, high stage at diagnosis, and aggressive genetic subtypes. VI. To assess different combinations of TM and synthesized 2 dimensional (2D) or DM in reader studies to assist in determining the optimum balance between diagnostic performance, radiation exposure and technique. VII. To estimate and compare breast-cancer-specific mortality between the two study arms. VIII. To estimate and compare the prevalence of breast cancer subtypes (luminal A, luminal B, HER2+, basal-like) low, medium or high proliferation via PAM50 proliferation signatures: p53 mutant-like or wild-type-like according to a validated p53 dependent signature; immune subtypes using a multigene signature of immune markers; deoxyribonucleic acid (DNA) repair phenotypes using a multigene signature of DNA repair genes; and a research version the 21-gene recurrence score in the two arms, overall and stratified on (a) whether cancers were detected through screening or as interval cancers, and (b) whether cancers were invasive or in situ. IX. To classify histologically malignant (true positive cases) and benign lesions (false positive cases) as normal-like or tumor-like using the PAM50 gene expression assay subtype (luminal A, luminal B, HER2, basal-like,), and low, medium, or high proliferation according to PAM50 proliferation signatures, p53 mutant-like or wild-type like according to a validated p53-dependent signature, immune active or inactive using a multi-gene immune signature, DNA repair high or low a DNA repair signature, and high or low/medium (med) risk based on the 21- gene recurrence assay. X. To assess the agreement between local and expert study pathologists for all breast lesions (benign and malignant) biopsied during the study. XI. To create a blood and buccal cell biobank for future biomarker and genetic testing. XII. To compare health care utilization (including cancer care received) and cost of an episode of breast cancer screening by TM versus DM, overall and within subsets as described in Aim II. XIII. To implement a centralized quality control (QC) monitoring program for both 2D digital mammography (DM) and tomosynthesis (TM), which provides rapid feedback on image quality, using quantitative tools, taking advantage of the automated analysis of digital images. XIV. To assess temporal and site-to site variations in image quality, breast radiation dose, and other quality control parameters in TM vs. DM. XV. To refine and implement task-based measures of image quality to assess the effects of technical parameters, including machine type, and detector spatial and contrast resolution on measures of diagnostic accuracy for TM. XVI. To evaluate which QC tests are useful for determination of image quality and those that are predictive of device failure, in order to recommend an optimal QC program for TM. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo bilateral screening DM with standard craniocaudal (CC) and mediolateral oblique (MLO) views at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal. Patients may optional blood and buccal sample collection at baseline. ARM B: Patients undergo manufacturer-defined screening TM at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal. Patients may optional blood and buccal sample collection at baseline. After completion of study, patients are followed up for 3-8 years after study entry, dependent on when patients enroll.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its NCI Community Oncology Research Program (NCORP) and National Clinical Trials Network (NCTN).
This short video features members of the study team discussing the trial.