NCT03377036

Brief Summary

This study is a randomized, multicenter, multivendor, controlled, diagnostic superiority trial to compare digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) versus standard 2D full-field digital mammography (2D-FFDM) regarding the effectiveness as screening modality.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99,689

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

21 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2018Mar 2027

First Submitted

Initial submission to the registry

December 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

July 5, 2018

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

8.7 years

First QC Date

December 13, 2017

Last Update Submit

January 21, 2026

Conditions

Breast Cancer Screening

Keywords

Breast CancerPopulation-based ScreeningDigital Breast Tomosynthesis plus synthesized MammographyReconstructed MammographyFull-Field Digital Mammography (FFDM)Multicentric Randomized Controlled TrialDiagnostic PerformanceRecall RateInterval Cancer

Outcome Measures

Primary Outcomes (2)

  • Detection rate of invasive breast cancers

    Number of women with screening-detected invasive breast cancer divided by the number of all women screened. A screening-detected breast cancer is classified as invasive carcinoma if the pT category (pathological tumor size) of the TNM classification falls into one of the following categories: pT1mic, pT1a, pT1b, pT1c, pT1, pT2, pT3, pT4a, pT4b, pT4c, pT4d, pT4, pTX (for evaluation purpose pTX defines histologically approved invasive breast cancer with missing tumor diameter) or the final pathological categorization has been done after neoadjuvant therapy (ypT), implying an invasive cancer prior to therapy.

    Routine screening visit

  • Cumulative 24 months incidence of interval cancers

    The 24 months incidence of interval cancers is defined as the number of women that develop a ductal carcinoma in situ or an invasive breast cancer in the 24 months interval after a negative screening examination divided by the number of all women with a negative screening result.

    24 months after routine screening visit

Secondary Outcomes (5)

  • Detection rate of ductal carcinoma in situ (DCIS)

    Routine screening visit

  • Detection rate of tumor category pT1

    Routine screening visit

  • Recall rate for further assessment

    Routine Screening Visit

  • Positive predictive value of recall for further assessment (PPV1)

    Routine screening visit

  • Cumulative 12 months incidence of interval cancers

    12 months after routine screening visit

Study Arms (2)

DBT+s2D

EXPERIMENTAL

Digital breast tomosynthesis plus synthesized 2D mammograms

Diagnostic Test: DBT+s2D

2D-FFDM

ACTIVE COMPARATOR

2D full-field digital mammography

Diagnostic Test: 2D-FFDM

Interventions

2D-FFDMDIAGNOSTIC_TEST

2D full-field digital mammography

2D-FFDM
DBT+s2DDIAGNOSTIC_TEST

Digital breast tomosynthesis plus synthesized 2D mammograms

DBT+s2D

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women eligible to participate in the National Mammography Screening Program of Germany
  • Informed decision for mammography screening
  • Written informed consent
  • No prior participation in the TOSYMA trial

You may not qualify if:

  • Breast cancer up to 5 years prior to study invitation
  • Previous mammography examination \< 12 months,
  • Breast implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Screening-Einheit Hannover; Mammographie-Einheit Hannover

Hanover, Lower Saxony, 30449, Germany

Location

Screening-Einheit Niedersachsen Nordost; Mammographie-Einheit Lüneburg

Lüneburg, Lower Saxony, 21337, Germany

Location

Screening-Einheit Niedersachsen Nord; Mammographie-Einheit Stade

Stade, Lower Saxony, 21680, Germany

Location

Screening-Einheit Niedersachsen Mitte; Mammographie-Einheit Vechta

Vechta, Lower Saxony, 49377, Germany

Location

Screening-Einheit Niedersachsen Nordwest; Mammographie-Einheit Wilhelmshaven

Wilhelmshaven, Lower Saxony, 26382, Germany

Location

Screening-Einheit Aachen-Düren-Heinsberg; Mammographie-Einheit Aachen

Aachen, North Rhine-Westphalia, 52062, Germany

Location

Referenz-Screening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Ahlen

Ahlen, North Rhine-Westphalia, 59227, Germany

Location

Screening-Einheit Köln rechtsrheinisch, Leverkusen, Rhein.-Berg. Kreis, Oberbergischer Kreis; Mammographie-Einheit Bergisch Gladbach

Bergisch Gladbach, North Rhine-Westphalia, 51429, Germany

Location

Screening-Einheit Bielefeld, Gütersloh; Mammographie-Einheit Bielefeld

Bielefeld, North Rhine-Westphalia, 33062, Germany

Location

Screening-Einheit Münster-Süd; Mammographie-Einheit Coesfeld

Coesfeld, North Rhine-Westphalia, 48653, Germany

Location

Screening-Einheit Duisburg; Mammographie-Einheit Duisburg

Duisburg, North Rhine-Westphalia, 47057, Germany

Location

Screening-Einheit Gelsenkirchen, Kreis Recklinghausen, Bottrop; Mammographie-Einheit Gelsenkirchen

Gelsenkirchen, North Rhine-Westphalia, 45894, Germany

Location

Screening-Einheit Minden-Lübbecke, Herford; Mammographie-Einheit Herford

Herford, North Rhine-Westphalia, 32052, Germany

Location

Screening-Einheit Mönchengladbach, Krefeld, Viersen; Mammographie-Einheit Krefeld

Krefeld, North Rhine-Westphalia, 47805, Germany

Location

Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Lippstadt

Lippstadt, North Rhine-Westphalia, 59555, Germany

Location

Referenz-Screeening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Münster-Nord

Münster, North Rhine-Westphalia, 48143, Germany

Location

Screening-Einheit Münster-Süd; Mammographie-Einheit Münster

Münster, North Rhine-Westphalia, 48153, Germany

Location

Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Paderborn

Paderborn, North Rhine-Westphalia, 33098, Germany

Location

Screening-Einheit Märkischer Kreis, Hamm, Unna; Mammographie-Einheit Schwerte

Schwerte, North Rhine-Westphalia, 58239, Germany

Location

Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Solingen-Mitte

Solingen, North Rhine-Westphalia, 42651, Germany

Location

Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Wuppertal-Elberfeld

Wuppertal, North Rhine-Westphalia, 42109, Germany

Location

Related Publications (3)

  • Weigel S, Gerss J, Hense HW, Krischke M, Sommer A, Czwoydzinski J, Lenzen H, Kerschke L, Spieker K, Dickmaenken S, Baier S, Urban M, Hecht G, Heidinger O, Kieschke J, Heindel W. Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial. BMJ Open. 2018 May 14;8(5):e020475. doi: 10.1136/bmjopen-2017-020475.

    PMID: 29764880BACKGROUND

  • Weigel S, Heindel W, Hense HW, Decker T, Gerss J, Kerschke L; TOSYMA Screening Trial Study Group. Breast Density and Breast Cancer Screening with Digital Breast Tomosynthesis: A TOSYMA Trial Subanalysis. Radiology. 2023 Feb;306(2):e221006. doi: 10.1148/radiol.221006. Epub 2022 Oct 4.

    PMID: 36194110DERIVED

  • Heindel W, Weigel S, Gerss J, Hense HW, Sommer A, Krischke M, Kerschke L; TOSYMA Screening Trial Study Group. Digital breast tomosynthesis plus synthesised mammography versus digital screening mammography for the detection of invasive breast cancer (TOSYMA): a multicentre, open-label, randomised, controlled, superiority trial. Lancet Oncol. 2022 May;23(5):601-611. doi: 10.1016/S1470-2045(22)00194-2. Epub 2022 Apr 12.

    PMID: 35427470DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Walter Heindel, MD, PhD

    University Clinic for Radiology, University of Muenster / University Hospital Muenster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Participants will be randomized to either Digital Breast Tomosynthesis plus synthesized 2D mammograms (DBT+s2D) or 2D Full-Field Digital Mammography (2D-FFDM)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 19, 2017

Study Start

July 5, 2018

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

DE(21)