Breast CancerMAITANCT04461808
Tomosynthesis as Primary Test for Breast Cancer Screening
A study testing tomosynthesis + synthetic 2D and digital mammography in people with Breast Cancer, run by Azienda USL Reggio Emilia - IRCCS at 4 sites in Italy.
Trial summary
Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- tomosynthesis + synthetic 2D and digital mammography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,156 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Mar 2019to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women scheduled for a new round of mammographic screening
- resident in the province
Who cannot join
- previous breast cancer diagnosis
- pregnancy or suspicion of pregnancy
- presence of BRCA1/2 gene mutation
- Previous Digital Breast Tomosynthesis performed
- unable to understand informed consent
- chemotherapy in progress
- presence of breast implant
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
IRCCS Policlinico San Donato
Milan
Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
Reggio Emilia, Italy, 42122
Azienda Ospedaliera Universitaria Integrata
Verona
Azienda Ulss 9 Scaligera
Verona
About this study
Official title: Tomosynthesis as Primary Test for Breast Cancer Screening: A Multicenter Randomized Controlled Trial
Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers.
Read the detailed description
This is a companion study of the other Italian studies on tomosyntesis as primary screening test for breast cancer: RETomo (NCT02698202), PROTEUS (NCT02590315), IMPETO (NCT03587259). The investigators conduct a randomized trial in three centres with a protocol that is similar to that of the other three studies. As for IMPETO and differently from the RETomo and PROTEUS studies, the intervention will be tomosynthesis + synthetic 2D.
In the three centres about 8000 women will be recruited (4000 in the experimental arm and 4000 in the control arm).
The study will compare the performance of tomosynthesis plus synthetic 2D vs digital mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers. Women 50 to 65 years old will be screened once according to randomization arm for one round, then all will be screened with digital mammography after two years.
The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate excess overdiagnosis comparing overall cumulative incidence after two or three rounds of screening.
Women will be asked for informed consent when they attend the mammography. If they accept they will be randomised to one of the two arms.
All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.
- Conditions
- Breast Cancer
- Being tested
- tomosynthesis + synthetic 2D, digital mammography
- Keywords
- breast cancer screening, tomosynthesis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tomosynthesis + synthetic 2DDiagnostic test
Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.
After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.
digital mammographyDiagnostic test
Women will be screened for one round digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.
After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.
| Study group | Role | What they receive |
|---|---|---|
| Tomosynthesis + synthetic 2D | Experimental | Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.
After two years (one years for women 45-49 yo) women will be re-screened with digital mammography. Receives: Diagnostic Test: tomosynthesis + synthetic 2D |
| Digital Mammography | Active comparator | Women will be screened for digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.
After two years (one years for women 45-49 yo) women will be re-screened with digital mammography. Receives: Diagnostic Test: digital mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
advanced cancer incidence
cumulative incidence of T2+ cancers after first screening round
Measured: 2 years (+9 months to complete second round assessment)
advanced cancer incidence
cumulative incidence of T2+ cancers after first screening round
Measured: 4 years (+9 months to complete third round assessment)
interval cancer incidence
incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome.
Measured: 2 years for 50-65 years old women
interval cancer incidence
incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome.
Measured: 1 year for 45-49 years old women
Secondary outcomes (9)
overall cumulative incidence
overall cumulative incidence of breast cancer, including ductal carcinoma in situ. This outcome is a proxy of the excess over-diagnosis eventually induced by tomosynthesis compared with digital mammography.
Measured: 2 years (+9 months to complete second round assessment)
overall cumulative incidence
overall cumulative incidence of breast cancer, including ductal carcinoma in situ. This outcome is a proxy of the excess over-diagnosis eventually induced by tomosynthesis compared with digital mammography.
Measured: 4 years (+9 months to complete second round assessment)
detection rate
cancer detected by the screening round on total screened women
Measured: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
recall rate
number of women referred to assessment after the first leve screening test on total screened women
Measured: This outcome is measured at the baseline screening.
positive predictive value
proportion of cancer among women recalled for assessment
Measured: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
Detection rate of ductal carcinoma in situ
ductal carcinoma in situ detected by the screening round on total screened women
Measured: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
biopsy rate
number of women undergoing biopsy after the first leve screening test on total screened women
Measured: This outcome is measured at the baseline screening.
x-ray dose
average glandular dose receive by women during first level test
Measured: This outcome is measured at the baseline screening.
reading time
time needed to read an imaging first level examination
Measured: This outcome is measured at the baseline screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Mar 2019
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women 45-65 participating in the mammographic screening program will be randomized to one round of screening with tomosynthesis + synthetic 2D or with digital mammography. Then all women will be re-screened after 2 years (1 year for women 45-49) for at least one round with digital mammography.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10,156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461808
- Sponsor's protocol ID
- RF-2016-02363686
- Acronym
- MAITA
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2020
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomosynthesis as Primary Test for Breast Cancer Screening: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04461808
- Acronym / sponsor ID
- MAITA / RF-2016-02363686
- Conditions
- Breast Cancer
- Keywords
- breast cancer screening, tomosynthesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,156 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers.
Detailed description
This is a companion study of the other Italian studies on tomosyntesis as primary screening test for breast cancer: RETomo (NCT02698202), PROTEUS (NCT02590315), IMPETO (NCT03587259). The investigators conduct a randomized trial in three centres with a protocol that is similar to that of the other three studies. As for IMPETO and differently from the RETomo and PROTEUS studies, the intervention will be tomosynthesis + synthetic 2D.
In the three centres about 8000 women will be recruited (4000 in the experimental arm and 4000 in the control arm).
The study will compare the performance of tomosynthesis plus synthetic 2D vs digital mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers. Women 50 to 65 years old will be screened once according to randomization arm for one round, then all will be screened with digital mammography after two years.
The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate excess overdiagnosis comparing overall cumulative incidence after two or three rounds of screening.
Women will be asked for informed consent when they attend the mammography. If they accept they will be randomised to one of the two arms.
All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Women 45-65 participating in the mammographic screening program will be randomized to one round of screening with tomosynthesis + synthetic 2D or with digital mammography. Then all women will be re-screened after 2 years (1 year for women 45-49) for at least one round with digital mammography.
| Arm | Type | Receives |
|---|---|---|
| Tomosynthesis + synthetic 2D | Experimental | Diagnostic Test: tomosynthesis + synthetic 2DWomen will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography. |
| Digital Mammography | Active comparator | Diagnostic Test: digital mammographyWomen will be screened for digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women scheduled for a new round of mammographic screening
- resident in the province
Key exclusion criteria (7 listed)
- previous breast cancer diagnosis
- pregnancy or suspicion of pregnancy
- presence of BRCA1/2 gene mutation
- Previous Digital Breast Tomosynthesis performed
- unable to understand informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tomosynthesis + synthetic 2DWomen will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography. | Diagnostic test | Tomosynthesis + synthetic 2D |
| digital mammographyWomen will be screened for one round digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography. | Diagnostic test | Digital Mammography |
Primary outcome
advanced cancer incidence
Time frame: 2 years (+9 months to complete second round assessment)
cumulative incidence of T2+ cancers after first screening round
advanced cancer incidence
Time frame: 4 years (+9 months to complete third round assessment)
cumulative incidence of T2+ cancers after first screening round
interval cancer incidence
Time frame: 2 years for 50-65 years old women
incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome.
interval cancer incidence
Time frame: 1 year for 45-49 years old women
incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome.
9 secondary outcomes
overall cumulative incidence
Time frame: 2 years (+9 months to complete second round assessment)
overall cumulative incidence
Time frame: 4 years (+9 months to complete second round assessment)
detection rate
Time frame: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
recall rate
Time frame: This outcome is measured at the baseline screening.
positive predictive value
Time frame: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
Detection rate of ductal carcinoma in situ
Time frame: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
biopsy rate
Time frame: This outcome is measured at the baseline screening.
x-ray dose
Time frame: This outcome is measured at the baseline screening.
reading time
Time frame: This outcome is measured at the baseline screening.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tomosynthesis + synthetic 2D and digital mammography in people with Breast Cancer, run by Azienda USL Reggio Emilia - IRCCS at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
advanced cancer incidence (time frame: 2 years (+9 months to complete second round assessment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.