Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography (TOSYMA)

University Hospital Muenster

Status: Active, not recruiting

Conditions: Breast Cancer Screening

Treatments: Diagnostic Test: 2D-FFDM; Diagnostic Test: DBT+s2D

Study type: Interventional

Funder types: Other

Identifiers

NCT03377036

HE1646/5-1 and HE1646/5-2 (Other Grant/Funding Number)

UKM14_0016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99,689 patients

Sex: Female

Ages: 50 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99,689 participants in 2 patient groups

DBT+s2D

Experimental group

Description:

Digital breast tomosynthesis plus synthesized 2D mammograms

Treatment:

Diagnostic Test: DBT+s2D

2D-FFDM

Active Comparator group

Description:

2D full-field digital mammography

Treatment:

Diagnostic Test: 2D-FFDM