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NCT Number: NCT03377036

Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography

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.

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Key information

Conditions

Breast Cancer Screening Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Screening-Einheit Hannover; Mammographie-Einheit Hannover, Hanover, Lower Saxony, Germany

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About this study

The primary objective of the study is to evaluate whether digital breast tomosynthesis plus synthesized 2D mammograms leads to a relevant increase in the detection rate of screening-detected invasive cancers compared to 2D full-field digital mammography in routine screening according to the European Guidelines. Furthermore, the incidence rate of interval cancers within a 24 months interval after screening will be compared between both study arms in order to investigate the potential for overdiagnosis.

According to the pre-defined order of both primary endpoints and the primary objective of the study in the planning phase, the initial sample size calculation was based solely on the first primary endpoint (invasive breast cancer detection rate). Given the increasing national and international attention of interval cancers to assess the impact of potential overdiagnosis caused by tomosynthesis, we have planned a sample size increase from 80,000 to 120,000 study participants to achieve a reasonable statistical power for the evaluation of both primary endpoints. The revised sample size calculation was carried out without knowledge of the data from the currently recruiting TOSYMA study, i.e. all planning assumptions were based on external data that do not belong to the ongoing study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

DBT+s2D

Diagnostic Test

Digital breast tomosynthesis plus synthesized 2D mammograms

2D-FFDM

Diagnostic Test

2D full-field digital mammography

Primary outcomes

  1. Detection rate of invasive breast cancers

    Time frame: Routine screening visit

    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.

  2. Cumulative 24 months incidence of interval cancers

    Time frame: 24 months after routine screening visit

    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.

Secondary outcomes

  1. Detection rate of ductal carcinoma in situ (DCIS)

    Time frame: Routine screening visit

    Number of women with screening-detected ductal carcinoma in situ (if the pT category of the TNM classification falls into the category pTis) divided by the number of all women screened.

  2. Detection rate of tumor category pT1

    Time frame: Routine screening visit

    Number of women with screening-detected invasive breast cancers of the category pT1 divided by the number of all women screened. A screening-detected breast cancer is classified as breast cancer of tumor category pT1 if tumor size is ≤ 20 mm in greatest dimension and the respective pT subcategory of the pTNM classification is one of the following: pT1mic, pT1a, pT1b, pT1c, pT1.

  3. Recall rate for further assessment

    Time frame: Routine Screening Visit

    Number of women with recalls for further assessment divided by the number of all women screened.

  4. Positive predictive value of recall for further assessment (PPV1)

    Time frame: Routine screening visit

    Number of women with screening-detected malignancies (ductal carcinoma in situ or invasive breast cancer) divided by the number of women with recalls for further assessment.

  5. Cumulative 12 months incidence of interval cancers

    Time frame: 12 months after routine screening visit

    The 12 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 12 months interval after a negative screening examination divided by the number of all women with a negative screening result.

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

Prospective Randomized Comparison of Digital Breast Tomosynthesis Plus Synthesized Images Versus Standard Full-field Digital Mammography in Population-based Screening (TOSYMA)

Acronym: TOSYMA

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2017
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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