Status:
ACTIVE_NOT_RECRUITING
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
Lead Sponsor:
ECOG-ACRIN Cancer Research Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Canadian Cancer Trials Group (CCTG)
Conditions:
Breast Screening
Eligibility:
FEMALE
45-74 years
Phase:
PHASE3
Brief Summary
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 ma...
Detailed Description
PRIMARY OBJECTIVES: I. To compare the proportions of participants in the tomosynthesis mammography (TM) and digital mammography (DM) study arms experiencing the occurrence of an ?advanced? breast can...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
108508 Patients enrolled
Trial Details
Trial ID
NCT03233191
Start Date
September 28 2017
End Date
December 31 2030
Last Update
December 29 2025
Active Locations (149)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
3
Banner-University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
4
University of Arizona College of Medicine Phoenix
Phoenix, Arizona, United States, 85006