Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography
- Conditions
- Breast Cancer Screening
- Interventions
- Diagnostic Test: 2D-FFDMDiagnostic Test: DBT+s2D
- Registration Number
- NCT03377036
- Lead Sponsor
- University Hospital Muenster
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 99689
- 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
- Breast cancer up to 5 years prior to study invitation
- Previous mammography examination < 12 months,
- Breast implants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2D-FFDM 2D-FFDM 2D full-field digital mammography DBT+s2D DBT+s2D Digital breast tomosynthesis plus synthesized 2D mammograms
- Primary Outcome Measures
Name Time Method Detection rate of invasive breast cancers 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.
Cumulative 24 months incidence of interval cancers 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 Outcome Measures
Name Time Method Recall rate for further assessment Routine Screening Visit Number of women with recalls for further assessment divided by the number of all women screened.
Cumulative 12 months incidence of interval cancers 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.
Positive predictive value of recall for further assessment (PPV1) 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.
Detection rate of ductal carcinoma in situ (DCIS) 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.
Detection rate of tumor category pT1 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.
Trial Locations
- Locations (21)
Screening-Einheit Niedersachsen Nord; Mammographie-Einheit Stade
🇩🇪Stade, Niedersachsen, Germany
Screening-Einheit Niedersachsen Mitte; Mammographie-Einheit Vechta
🇩🇪Vechta, Niedersachsen, Germany
Screening-Einheit Minden-Lübbecke, Herford; Mammographie-Einheit Herford
🇩🇪Herford, Nordrhein-Westfalen, Germany
Screening-Einheit Niedersachsen Nordost; Mammographie-Einheit Lüneburg
🇩🇪Lüneburg, Niedersachsen, Germany
Referenz-Screening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Ahlen
🇩🇪Ahlen, Nordrhein-Westfalen, Germany
Screening-Einheit Hannover; Mammographie-Einheit Hannover
🇩🇪Hannover, Niedersachsen, Germany
Screening-Einheit Niedersachsen Nordwest; Mammographie-Einheit Wilhelmshaven
🇩🇪Wilhelmshaven, Niedersachsen, Germany
Screening-Einheit Märkischer Kreis, Hamm, Unna; Mammographie-Einheit Schwerte
🇩🇪Schwerte, Nordrhein-Westfalen, Germany
Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Solingen-Mitte
🇩🇪Solingen, Nordrhein-Westfalen, Germany
Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Lippstadt
🇩🇪Lippstadt, Nordrhein-Westfalen, Germany
Screening-Einheit Bielefeld, Gütersloh; Mammographie-Einheit Bielefeld
🇩🇪Bielefeld, Nordrhein-Westfalen, Germany
Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Paderborn
🇩🇪Paderborn, Nordrhein-Westfalen, Germany
Screening-Einheit Köln rechtsrheinisch, Leverkusen, Rhein.-Berg. Kreis, Oberbergischer Kreis; Mammographie-Einheit Bergisch Gladbach
🇩🇪Bergisch Gladbach, Nordrhein-Westfalen, Germany
Screening-Einheit Duisburg; Mammographie-Einheit Duisburg
🇩🇪Duisburg, Nordrhein-Westfalen, Germany
Screening-Einheit Münster-Süd; Mammographie-Einheit Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Wuppertal-Elberfeld
🇩🇪Wuppertal, Nordrhein-Westfalen, Germany
Screening-Einheit Aachen-Düren-Heinsberg; Mammographie-Einheit Aachen
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Screening-Einheit Münster-Süd; Mammographie-Einheit Coesfeld
🇩🇪Coesfeld, Nordrhein-Westfalen, Germany
Screening-Einheit Mönchengladbach, Krefeld, Viersen; Mammographie-Einheit Krefeld
🇩🇪Krefeld, Nordrhein-Westfalen, Germany
Screening-Einheit Gelsenkirchen, Kreis Recklinghausen, Bottrop; Mammographie-Einheit Gelsenkirchen
🇩🇪Gelsenkirchen, Nordrhein-Westfalen, Germany
Referenz-Screeening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Münster-Nord
🇩🇪Münster, Nordrhein-Westfalen, Germany