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

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Status: Active

Description

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.

Eligibility Criteria

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 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 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 ** 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 two 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
  • 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

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu
Mobile
Mobile Infirmary Medical Center
Status: Active
Contact: Site Public Contact
Phone: 251-435-3942

Arizona

Phoenix
Maricopa Medical Center
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Mayo Clinic Hospital
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
University of Arizona College of Medicine Phoenix
Status: Active
Contact: Site Public Contact
Phone: 520-780-8241
Email: atvalencia@email.arizona.edu
Scottsdale
Scottsdale Medical Imaging Limited
Status: Active
Contact: Site Public Contact
Phone: 480-425-4170
Email: investigator@esmil.com

Arkansas

Little Rock
University of Arkansas for Medical Sciences
Status: Active
Contact: Site Public Contact
Phone: 501-686-8274

California

Bakersfield
Kern Radiology Medical Group Inc
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 661-326-9600
Los Angeles
Los Angeles County-USC Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 323-865-0451
San Francisco
Zuckerberg San Francisco General Hospital
Status: Active
Contact: Site Public Contact
Phone: 415-476-4082
Email: Paul.Couey@ucsf.edu

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Penrose-Saint Francis Healthcare
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Denver
The Women's Imaging Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Englewood
Radiology Imaging Associates
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-761-9190
Email: research@riaco.com
Lone Tree
UCHealth Lone Tree Health Center
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Delaware

Newark
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

Georgia

Atlanta
Northside Hospital
Status: Active
Contact: Site Public Contact
Phone: 404-303-3355
Email: ClinicalTrials@northside.com
Braselton
Northeast Georgia Medical Center Braselton
Status: Active
Contact: Site Public Contact
Phone: 770-219-8800
Email: cancerpatient.navigator@nghs.com
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org

Hawaii

Honolulu
Queen's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 808-545-8548

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact
Phone: 208-381-2774
Email: eslinget@slhs.org

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: Active
Contact: Site Public Contact
Phone: 312-864-5204
Danville
Carle on Fairchild
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Decatur
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu

Iowa

Des Moines
Mercy Medical Center - Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Louisiana

Baton Rouge
Mary Bird Perkins Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Woman's Hospital
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: Clinicalreserach@marybird.com
New Orleans
University Medical Center New Orleans
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu
Shreveport
Louisiana State University Health Sciences Center Shreveport
Status: Active
Contact: Site Public Contact
Phone: 318-813-1422
Email: JRowel@lsuhsc.edu

Maryland

Kensington
Kaiser Permanente - Kensington Medical Center
Status: Active
Contact: Site Public Contact
Phone: 301-816-7218

Massachusetts

Boston
Boston Medical Center
Status: Active
Contact: Site Public Contact
Phone: 617-638-8265
Worcester
University of Massachusetts Medical School
Status: Active
Contact: Site Public Contact
Phone: 508-856-3216
Email: cancer.research@umassmed.edu

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Battle Creek
Bronson Battle Creek
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Detroit
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Grand Rapids
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org

Minnesota

Duluth
Essentia Health Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Minneapolis
Hennepin County Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Nevada

Carson City
Carson Tahoe Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Jersey

New Brunswick
Saint Peter's University Hospital
Status: Active
Contact: Site Public Contact
Phone: 732-745-8600ext6163
Email: kcovert@saintpetersuh.com
Red Bank
Riverview Medical Center / Booker Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 732-530-2382

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org

New York

Bronx
Montefiore Medical Center-Einstein Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Weiler Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Elmira
Arnot Ogden Medical Center / Falck Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 607-271-7000
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-305-6361
Email: nr2616@cumc.columbia.edu
NYP / Weill Cornell Medical Center
Status: Active
Contact: Site Public Contact
Phone: 212-746-1848

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Durham
Duke University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-275-3853
Hillsborough
University of North Carolina-Hillsborough Campus
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Ohio

Canton
Aultman Health Foundation
Status: Active
Contact: Site Public Contact
Phone: 330-363-7274
Email: ClinicalReserachDept@aultman.com
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu

Pennsylvania

Easton
Easton Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-250-4000
Philadelphia
Fox Chase Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 215-728-4790
Pittsburgh
Allegheny General Hospital
Status: Active
Contact: Site Public Contact
Phone: 877-284-2000
Wexford
Wexford Health and Wellness Pavilion
Status: Active
Contact: Site Public Contact
Phone: 412-359-3043
Email: ddefazio@wpahs.org

Puerto Rico

San Juan
San Juan City Hospital
Status: Active
Contact: Site Public Contact
Phone: 787-763-1296

South Carolina

Mount Pleasant
MUSC Health East Cooper
Status: Active
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
Spartanburg
Spartanburg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org

Tennessee

Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org
Baptist Memorial Hospital for Women
Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org
Nashville
Vanderbilt Breast Center at One Hundred Oaks
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Houston
M D Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 434-243-6303
Email: PAS9E@virginia.edu
Norfolk
Sentara Leigh Hospital
Status: Active
Contact: Site Public Contact
Phone: 757-388-5109
Email: djoverto@sentara.com
Sentara Norfolk General Hospital
Status: Active
Contact: Site Public Contact
Phone: 757-388-2406

Washington

Seattle
Swedish Medical Center-First Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org

West Virginia

Morgantown
West Virginia University Healthcare
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Appleton
ThedaCare Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 920-364-3605
Email: Noreen.Wynn@thedacare.org
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Medical Center-Marshfield
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Mukwonago
ProHealth D N Greenwald Center
Status: Active
Contact: Site Public Contact
Email: research.institute@phci.org
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 262-928-7878
Waukesha
UW Cancer Center at ProHealth Care
Status: Active
Contact: Site Public Contact
Phone: 262-928-5539
Email: Chanda.miller@phci.org

British Columbia

Vancouver
BCCA-Vancouver Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 888-939-3333

Ontario

London
Saint Joseph's Health Centre
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Ottawa
Ottawa Hospital and Cancer Center-General Campus
Status: Active
Contact: Site Public Contact
Phone: 613-761-4395
Toronto
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Status: Active
Contact: Site Public Contact
Phone: 416-480-5000

Quebec

Montreal
Hopital Du Sacre-Coeur de Montreal
Status: Active
Contact: Site Public Contact
Phone: 514-338-2172
Quebec City
CHU de Quebec-Hopital du Saint-Sacrement (HSS)
Status: Active
Contact: Site Public Contact
Phone: 418-649-5593
Email: jbegin@uresp.ulaval.ca

Argentina

Buenos Aires
CERIM
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare the proportions of participants in the tomosynthesis (TM) and digital mammography (DM) study arms experiencing the occurrence of an “advanced” breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4).

SECONDARY OBJECTIVES:

I. To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms.

II. To compare the diagnostic performance of TM and 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, and p53 mutant-like or wild-type-like according to a validated p53 dependent signature in the two arms, overall and stratified on whether cancers were detected through screening or as interval cancers, and 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, and p53 mutant-like or wild-type-like according to a validated p53-dependent signature.

X. To assess the agreement between local and expert study pathologists for all breast lesions (benign and malignant) biopsied during the 4.5 years of screening with TM or DM.

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.

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.

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.

After completion of study, patients are followed up for at least 4.5-8 years after study entry.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Screening

Lead Organization

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Etta D. Pisano

Trial IDs

Primary ID EA1151
Secondary IDs ECOG-ACRIN-EA1151, NCI-2017-01111
Clinicaltrials.gov ID NCT03233191