Active — Not RecruitingPhase 3

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

United States, Argentina, Canada108,508 participantsStarted 2017-09-28

Plain-language 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 may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

Who can participate

Age range

45 Years – 74 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing digital tomosynthesis mammography — sometimes called 3D mammography — to standard 2D digital mammography over 4.5 years, so is one of these screening methods currently considered better than the other based on what's already known, or is that still an open question my doctor could help me think through?
2Since this trial is in Phase 3 and is actively running but no longer enrolling new participants, does that mean the results aren't published yet, and how should I factor that uncertainty into decisions about which type of mammogram screening I pursue right now?
3The trial's main goal is to track whether women end up diagnosed with advanced breast cancer over 4.5 years — does my personal risk level, family history, or breast density affect which screening approach my doctor would recommend for me in the meantime, regardless of this trial's findings?
4Since I can't join this trial anymore, are there other ways I can access 3D mammography screening as part of my regular care, and would my doctor recommend it over standard 2D mammography based on the evidence available today?
5Given that the trial is measuring outcomes over a long follow-up period, what screening schedule and imaging type does my doctor think makes the most sense for me right now while we're still waiting for more definitive data from studies like this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of women diagnosed with 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 follow up after the last screen

Timeframe: 4.5 years after last registration

Trial details

NCT IDNCT03233191

SponsorECOG-ACRIN Cancer Research Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More Breast Screening trials