Breast CancerPhase 4ProteusDonnaNCT02590315
Tomosynthesis Versus Digital Mammography in a Population-based Screening Program
A Phase 4 study testing Invitation for breast screening and random allocation, DBT and Conventional digital mammography. in people with Breast Cancer, run by Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte at 1 site in Italy.
Trial summary
Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis (DBT) is more sensitive and more specific than conventional digital mammography (DM). However, large randomised controlled trials (RCTs) are needed to confirm these promising results. Read more about this study
- Who is it for?
- Ages 46 to 68 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Invitation for breast screening and random allocation, DBT and Conventional digital mammography.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92,000 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2014to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 46 to 68 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asymptomatic women 45-68 years, residents in the Piedmont Region, attending the regional breast cancer screening program
Who cannot join
- Personal history of breast cancer
- A terminal illness
- Patients who are unable to give informed consent
- Breast implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Breast Tomosynthesis Versus Digital Mammography in a Population-based Screening Program. A Controlled Randomized Multicenter Trial
Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis (DBT) is more sensitive and more specific than conventional digital mammography (DM). However, large randomised controlled trials (RCTs) are needed to confirm these promising results. Furthermore, potential side effects of DBT in the screening setting have to be properly evaluated. In particular, the major concern is about overdiagnosis and its consequences; overdiagnosis refers to the detection of cancers at screening, which would not have become clinically apparent in the woman's lifetime.
This RCT was designed to compare benefits and harms of DBT in a population-based screening program with conventional DM. The primary outcome parameter will be the difference between the two tests in rates of advanced cancers detected at the subsequent round and interval cancers (within the first two years after the study screening round). Secondary outcomes measures will be diagnostic performance indicators for organised breast screening (i.e, cancer detection rate, recall rate, false positive rate, positive predictive value), parameters used in cost-effectiveness analysis, pathologic and biological characteristics of screen-detected cancers.
Read the detailed description
Design of the study This trial will involve several hospital centres within the organised breast screening in the Italian region of Piedmont.
An invitation letter to participate in a randomised screening trial comparing DBT versus DM will be mailed to all women, 46-68 years old, living in the Piedmont Region, and eligible for invitation to the regional mammography screening program. Women who attend the centres for screening and consent to the study will be randomly allocated either to DBT or DM arm.
Women in the DM arm will be screened with bilateral, two-views digital mammography examination. Women in the DBT arm will be screened with the bilateral two-views combo mode (DM and DBT images acquired in a single compression). In both screening arms, examinations will be independently read by two expert screening radiologists. In the DBT arm, each reading will be randomly allocated (on a per-case basis) to one of these three modes: DM plus DBT (DBT is read only after initial DM interpretation), DBT plus DM (DM is read only after DBT interpretation) and "concurrent mode" (both DBT and DM are read simultaneously).
In both screening arms, participants will be recalled for further examination if indicated by at least one radiologist (without consensus or arbitration). At the subsequent round all participants will be invited to DM only. Interval cancers and advanced cancers screen-detected at the next round will be recorded. Pathological and biological parameters of screen-detected cancers (e.g, stage, grading, hormone receptors, HER2) in both screening arms will be measured to investigate overdiagnosis.
With a sample size of 23,000 and 69,000 women in the DBT and DM arm respectively, the investigators will be able to observe a significant decrease in interval cancers and advanced cancers rate of at least 50% (power 80%, two tails). The collected data will be also used to perform analyses on radiological work-flow and workload, and cost-outcome and cost-effectiveness.
- Conditions
- Breast Cancer
- Being tested
- Invitation for breast screening and random allocation, DBT, Conventional digital mammography.
- Keywords
- BC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation for breast screening and random allocationOther
Also called Invitation
Invitation for breast screening; Women who consent to take part in the trial will be randomised to DBT or DM.
DBTDevice
Also called Combo-mode DBT, 3D mammography
Combo-mode DBT. DBT participants will have an additional radiation exposure for breast tomosynthesis.
Conventional digital mammography.Device
Also called DM
Conventional digital mammography.
| Study group | Role | What they receive |
|---|---|---|
| Digital Breast Tomosynthesis - DBT | Experimental | Invitation for breast screening and random allocation. Participants randomised to DBT will be screened with bilateral, two-view combo mode (DBT images are obtained with DM images). DBT participants will have an additional radiation exposure for the combined DM and DBT examinations. Receives: Other: Invitation for breast screening and random allocation; Device: DBT |
| Conventional digital mammography - DM | Active comparator | Invitation for breast screening and random allocation. Participants randomised to DM will be screened with bilateral, two-view DM. Receives: Other: Invitation for breast screening and random allocation; Device: Conventional digital mammography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cancers after the first study screening round. Data on interval cancers (within 24 months of a negative study examination) and on advanced screen-detected cancers at the subsequent screen among participants will be collected.
Measured: 5 years
Secondary outcomes (4)
Cancer detection rate of DBT versus DM screening
Measured: 3 years
Recall Rate
Measured: 5 years
False Positive Rate
Measured: 3 years
Positive Predictive Value
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2021 (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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Piemonte, im3D S.p.A.
- Responsible party
- Sponsor
- Investigators
- Alfonso Frigerio, Dr, Principal investigator, SCDO Epidemiologia dei Tumori, AOU Città della Salute e della Scienza di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590315
- Sponsor's protocol ID
- CPO-PROTEUSDONNA
- Acronym
- ProteusDonna
- Status last verified
- Jan 2019
- First submitted
- 26 Oct 2015
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Breast Tomosynthesis Versus Digital Mammography in a Population-based Screening Program. A Controlled Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT02590315
- Acronym / sponsor ID
- ProteusDonna / CPO-PROTEUSDONNA
- Conditions
- Breast Cancer
- Keywords
- BC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92,000 participants (estimated)
- Lead sponsor
- Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica PiemonteUniversity, hospital or other
- Collaborators
- Regione Piemonte, im3D S.p.A.
- Study start
- Dec 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- 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.
Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis (DBT) is more sensitive and more specific than conventional digital mammography (DM). However, large randomised controlled trials (RCTs) are needed to confirm these promising results. Furthermore, potential side effects of DBT in the screening setting have to be properly evaluated. In particular, the major concern is about overdiagnosis and its consequences; overdiagnosis refers to the detection of cancers at screening, which would not have become clinically apparent in the woman's lifetime.
This RCT was designed to compare benefits and harms of DBT in a population-based screening program with conventional DM. The primary outcome parameter will be the difference between the two tests in rates of advanced cancers detected at the subsequent round and interval cancers (within the first two years after the study screening round). Secondary outcomes measures will be diagnostic performance indicators for organised breast screening (i.e, cancer detection rate, recall rate, false positive rate, positive predictive value), parameters used in cost-effectiveness analysis, pathologic and biological characteristics of screen-detected cancers.
Detailed description
Design of the study This trial will involve several hospital centres within the organised breast screening in the Italian region of Piedmont.
An invitation letter to participate in a randomised screening trial comparing DBT versus DM will be mailed to all women, 46-68 years old, living in the Piedmont Region, and eligible for invitation to the regional mammography screening program. Women who attend the centres for screening and consent to the study will be randomly allocated either to DBT or DM arm.
Women in the DM arm will be screened with bilateral, two-views digital mammography examination. Women in the DBT arm will be screened with the bilateral two-views combo mode (DM and DBT images acquired in a single compression). In both screening arms, examinations will be independently read by two expert screening radiologists. In the DBT arm, each reading will be randomly allocated (on a per-case basis) to one of these three modes: DM plus DBT (DBT is read only after initial DM interpretation), DBT plus DM (DM is read only after DBT interpretation) and "concurrent mode" (both DBT and DM are read simultaneously).
In both screening arms, participants will be recalled for further examination if indicated by at least one radiologist (without consensus or arbitration). At the subsequent round all participants will be invited to DM only. Interval cancers and advanced cancers screen-detected at the next round will be recorded. Pathological and biological parameters of screen-detected cancers (e.g, stage, grading, hormone receptors, HER2) in both screening arms will be measured to investigate overdiagnosis.
With a sample size of 23,000 and 69,000 women in the DBT and DM arm respectively, the investigators will be able to observe a significant decrease in interval cancers and advanced cancers rate of at least 50% (power 80%, two tails). The collected data will be also used to perform analyses on radiological work-flow and workload, and cost-outcome and cost-effectiveness.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Breast Tomosynthesis - DBT | Experimental | Other: Invitation for breast screening and random allocation, Device: DBTInvitation for breast screening and random allocation. Participants randomised to DBT will be screened with bilateral, two-view combo mode (DBT images are obtained with DM images). DBT participants will have an additional radiation exposure for the combined DM and DBT examinations. |
| Conventional digital mammography - DM | Active comparator | Other: Invitation for breast screening and random allocation, Device: Conventional digital mammography.Invitation for breast screening and random allocation. Participants randomised to DM will be screened with bilateral, two-view DM. |
Who may qualify
- Ages
- 46 to 68 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Asymptomatic women 45-68 years, residents in the Piedmont Region, attending the regional breast cancer screening program
Key exclusion criteria (4 listed)
- Personal history of breast cancer
- A terminal illness
- Patients who are unable to give informed consent
- Breast implants
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 |
|---|---|---|
| Invitation for breast screening and random allocationAlso: InvitationInvitation for breast screening; Women who consent to take part in the trial will be randomised to DBT or DM. | Other | Conventional digital mammography - DM, Digital Breast Tomosynthesis - DBT |
| DBTAlso: Combo-mode DBT, 3D mammographyCombo-mode DBT. DBT participants will have an additional radiation exposure for breast tomosynthesis. | Device | Digital Breast Tomosynthesis - DBT |
| Conventional digital mammography.Also: DMConventional digital mammography. | Device | Conventional digital mammography - DM |
Primary outcome
Rate of cancers after the first study screening round. Data on interval cancers (within 24 months of a negative study examination) and on advanced screen-detected cancers at the subsequent screen among participants will be collected.
Time frame: 5 years
4 secondary outcomes
Cancer detection rate of DBT versus DM screening
Time frame: 3 years
Recall Rate
Time frame: 5 years
False Positive Rate
Time frame: 3 years
Positive Predictive Value
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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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.
Alfonso Frigerio, Dr principal investigator
SCDO Epidemiologia dei Tumori, AOU Città della Salute e della Scienza di Torino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Invitation for breast screening and random allocation, DBT and Conventional digital mammography. in people with Breast Cancer, run by Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte at 1 site 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Rate of cancers after the first study screening round. Data on interval cancers (within 24 months of a negative study examination) and on advanced screen-detected cancers at the subsequent screen among participants will be collected. (time frame: 5 years). 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 31 Jan 2019; AzTrials last refreshed its copy on 28 Oct 2026.