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

NCT03233191 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108508

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Breast Screening

Interventions

PROCEDURE

Digital Mammography

Undergo DM

PROCEDURE

Digital Tomosynthesis Mammography

Undergo TM

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Canadian Cancer Trials Group (CCTG)

    collaborator UNKNOWN
  • ECOG-ACRIN Cancer Research Group

    lead NETWORK

Principal Investigators

  • Etta Pisano · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Italy
  • Peru
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03233191 on ClinicalTrials.gov