Breast NeoplasmsRIBBSNCT05675085
Risk-Based Breast Screening in Young Women
A study testing Personalized screening protocol in people with Breast Neoplasms, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial summary
The RIBBS study is a single-arm single-center study that aims to evaluate the effectiveness of a risk-based breast screening model using digital breast tomosynthesis (DBT) as the baseline test, quantitative individual breast density to guide supplemental ultrasound (US) imaging for dense breasts, and individual risk… Read more about this study
- Who is it for?
- Ages 45 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Personalized screening protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,269 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2020to 31 Jan 2026
- Phase
- Interventional
- 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 45 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Aged 45 years old
- Resident in the provinces of Padua and Rovigo (Italy)
- Willing and able to give written informed consent
- Willing and able to comply with scheduled visits, tests, and other procedures
Who cannot join
- Recent mammography
- Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS)
- Known BRCA carrier or PALB2 or ≥50% risk
- Psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up
- Pregnant or breastfeeding
- Unable to give informed consent
- Current participation in another interventional breast screening trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk-Based Breast Screening (RIBBS) in Young Women: Personalized Imaging Protocols
The RIBBS study is a single-arm single-center study that aims to evaluate the effectiveness of a risk-based breast screening model using digital breast tomosynthesis (DBT) as the baseline test, quantitative individual breast density to guide supplemental ultrasound (US) imaging for dense breasts, and individual risk (calculated taking into account breast density) to guide the screening interval (annual or biennial).
Invited 45-year-old women are differentiated into five different screening protocols (based on breast density and risk), and screened according to a personalized model until they turn 50 and return to routine screening.
Read more
The only primary endpoint in this study is the cumulative incidence of advanced breast cancers (stage II and above). This endpoint will be evaluated at the end of the five-year intervention period and at 10 years.
The results of the personalized screening model will be compared with those obtained from an observational cohort from a neighboring region in which a "one-size-fits-all" approach involving annual mammography for women aged 45-49 years is used. The comparison will be conducted with the hypothesis of superiority of the personalized screening model.
Read the detailed description
The incidence of breast cancer in women aged 45 to 49 is not much lower than in women aged 50 to 54. However, while the Italian Health System offers mammography screening to all women aged 50 to 69 every two years, women aged 45 to 49 are invited for annual mammography screening in only a few regions. Breast density, i.e. the amount of fibroglandular tissue, more present in young women, decreases the performance of mammography by reducing the detectability of breast cancer; consequently, breast cancer in women with dense breasts can often be found only when it is larger and thus at a more advanced stage. In addition, breast density is an independent risk for breast cancer.
The RIBBS study was designed to use the first round of screening to identify women with dense breasts and those at increased risk of breast cancer, and use this information to tailor the subsequent screening protocol, including supplemental US imaging for women with dense breasts, and establishing the frequency of screening cycles according to risk category.
The reference imaging is digital breast tomosynthesis, which has already demonstrated greater sensitivity than digital mammography in the "standard" screening age (50-69).
Volumetric breast density (VBD) is calculated from DBT, and lifetime risk (LTR) is obtained from the Tyrer-Cuzick risk model which also includes breast drnsity as a risk factor.
After the first round of screening, women are divided into five groups: women with non-dense breasts and low breast cancer risk are screened every two years with DBT alone; women with dense breasts and low breast cancer risk are screened every two years with DBT plus additional ultrasound (DBT+US); women with non-dense breasts and intermediate risk of breast cancer are screened annually with DBT alone; women with dense breasts and intermediate risk of breast cancer are screened annually with DBT+US; finally, high-risk women with a family history of breast cancer (w/wo hereditary factors) are monitored with annual MRI and tomosynthesis.
Our study hypothesizes that a screening model stratified by breast density and risk is more effective and sustainable in reducing the incidence of advanced breast cancer than standard annual mammography screening.
- Conditions
- Breast Neoplasms
- Being tested
- Personalized screening protocol
- Keywords
- Breast Neoplasms, Cancer Screening, Personalized Medicine, Mammographic Breast Density, Risk Assessment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized screening protocolDiagnostic test
At the first screening round (recruitment) all participating women had the same tests;
- Two-view tomosynthesis of both breasts
- Calculation of volumetric breast density (VBD)
- Calculation of lifetime risk (LTR) using the Tyrer-Cuzick model
At subsequent rounds:
- Women with non-dense breasts and low breast cancer risk are re-screened only with DBT every 2 years;
- Women with dense breasts and low breast cancer risk are re-screened with DBT+US every 2 years;
- Women with non-dense breasts and intermediate breast cancer risk are re-screened only with DBT every year;
- Women with dense breasts and intermediate breast cancer risk are re-screened with DBT+US every year;
- Women at high risk of breast cancer associated with a family history of breast cancer (w/wo hereditary factors) undergo DBT and MRI every year.
| Study group | Role | What they receive |
|---|---|---|
| RIBBS arm | Other | This clinical trial is a single-arm study in which asymptomatic 45-year-old women undergo a triple screening test: (1) two-view tomosynthesis of both breasts; (2) calculation of volumetric breast density (VBD); (3) assessment of breast cancer risk using the Tyrer-Cuzick model. Mean VBD and lifetime risk (LTR) are used to determine the type of imaging and frequency of subsequent screening cycles. Receives: Diagnostic Test: Personalized screening protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Advanced Cancers
Percentage of breast cancer cases diagnosed at staged II or beyond, either during the entire screening period or thereafter. Advanced cancers occurring up to 10 years after the end of the screening intervention will be included
Measured: Up to 15 years
Secondary outcomes (9)
Recall rate (RR)
Number of women recalled for further diagnostic evaluation per thousand women screened, also known as the BI-RADS abnormal interpretation rate
Measured: Up to 6 years
Cancer detection rate (CDR)
Number of cancers detected by screening test(s) per thousand women screened
Measured: Up to 6 years
Proportional Incidence of Interval Cancer
Number of women diagnosed with interval cancer (detected after a negative screening episode) divided by the expected number of breast cancer cases in the absence of screening
Measured: Up to 8 years
Total Assessment Rate
Number of women undergoing diagnostic evaluation per thousand women screened. Further breakdown into noninvasive and invasive assessment rates.
Measured: Up to 6 years
Surgical Referral Rate
Number of women referred to excisional biopsy or definitive surgical treatment per thousand women screened
Measured: Up to 6 years
Surgery Rate
Number of women undergoing excisional biopsy or definitive surgical treatment per thousand women screened
Measured: Up to 6 years
Benign Lesion Detection Rate
Number of women with any histologically diagnosed benign lesion per thousand women screened
Measured: Up to 6 years
Tumor-Stage Specific Detection Rate
Number of women with cancer detected by screening and classified by TNM tumor stage per thousand women screened
Measured: Up to 6 years
Regular Re-Screening Rate
Number of women who regularly undergo the specific screening protocol (within ± 3 months) between ages 45 and 49 per thousand women screened
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start20 Jan 2020
- Primary completion21 Dec 2021
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Regione del Veneto (Italy)
- Responsible party
- Sponsor
- Investigators
- Francesca Caumo, MD, Principal investigator, Istituto Oncologico Veneto IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675085
- Sponsor's protocol ID
- RIBBS 2019/37
- Acronym
- RIBBS
- Status last verified
- Oct 2023
- First submitted
- 1 Dec 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caumo F, Gennaro G, Ravaioli A, Baldan E, Bezzon E, Bottin S, Carlevaris P, Ciampani L, Coran A, Dal Bosco C, Del Genio S, Dalla Pieta A, Falcini F, Maggetto F, Manco G, Masiero T, Petrioli M, Polico I, Pisapia T, Zemella M, Zorzi M, Zovato S, Bucchi L. Personalized screening based on risk and density: prevalence data from the RIBBS study. Radiol Med. 2025 May;130(5):740-752. doi: 10.1007/s11547-025-01981-5. Epub 2025 Mar 21.
PubMed 40117106Gennaro G, Bucchi L, Ravaioli A, Zorzi M, Falcini F, Russo F, Caumo F. The risk-based breast screening (RIBBS) study protocol: a personalized screening model for young women. Radiol Med. 2024 May;129(5):727-736. doi: 10.1007/s11547-024-01797-9. Epub 2024 Mar 21.
PubMed 38512619
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-Based Breast Screening (RIBBS) in Young Women: Personalized Imaging Protocols
- ClinicalTrials.gov ID
- NCT05675085
- Acronym / sponsor ID
- RIBBS / RIBBS 2019/37
- Conditions
- Breast Neoplasms
- Keywords
- Breast Neoplasms, Cancer Screening, Personalized Medicine, Mammographic Breast Density, Risk Assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,269 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Collaborators
- Regione del Veneto (Italy)
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 9 Jan 2023 (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.
The RIBBS study is a single-arm single-center study that aims to evaluate the effectiveness of a risk-based breast screening model using digital breast tomosynthesis (DBT) as the baseline test, quantitative individual breast density to guide supplemental ultrasound (US) imaging for dense breasts, and individual risk (calculated taking into account breast density) to guide the screening interval (annual or biennial).
Invited 45-year-old women are differentiated into five different screening protocols (based on breast density and risk), and screened according to a personalized model until they turn 50 and return to routine screening.
The only primary endpoint in this study is the cumulative incidence of advanced breast cancers (stage II and above). This endpoint will be evaluated at the end of the five-year intervention period and at 10 years.
The results of the personalized screening model will be compared with those obtained from an observational cohort from a neighboring region in which a "one-size-fits-all" approach involving annual mammography for women aged 45-49 years is used. The comparison will be conducted with the hypothesis of superiority of the personalized screening model.
Detailed description
The incidence of breast cancer in women aged 45 to 49 is not much lower than in women aged 50 to 54. However, while the Italian Health System offers mammography screening to all women aged 50 to 69 every two years, women aged 45 to 49 are invited for annual mammography screening in only a few regions. Breast density, i.e. the amount of fibroglandular tissue, more present in young women, decreases the performance of mammography by reducing the detectability of breast cancer; consequently, breast cancer in women with dense breasts can often be found only when it is larger and thus at a more advanced stage. In addition, breast density is an independent risk for breast cancer.
The RIBBS study was designed to use the first round of screening to identify women with dense breasts and those at increased risk of breast cancer, and use this information to tailor the subsequent screening protocol, including supplemental US imaging for women with dense breasts, and establishing the frequency of screening cycles according to risk category.
The reference imaging is digital breast tomosynthesis, which has already demonstrated greater sensitivity than digital mammography in the "standard" screening age (50-69).
Volumetric breast density (VBD) is calculated from DBT, and lifetime risk (LTR) is obtained from the Tyrer-Cuzick risk model which also includes breast drnsity as a risk factor.
After the first round of screening, women are divided into five groups: women with non-dense breasts and low breast cancer risk are screened every two years with DBT alone; women with dense breasts and low breast cancer risk are screened every two years with DBT plus additional ultrasound (DBT+US); women with non-dense breasts and intermediate risk of breast cancer are screened annually with DBT alone; women with dense breasts and intermediate risk of breast cancer are screened annually with DBT+US; finally, high-risk women with a family history of breast cancer (w/wo hereditary factors) are monitored with annual MRI and tomosynthesis.
Our study hypothesizes that a screening model stratified by breast density and risk is more effective and sustainable in reducing the incidence of advanced breast cancer than standard annual mammography screening.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIBBS arm | Other | Diagnostic Test: Personalized screening protocolThis clinical trial is a single-arm study in which asymptomatic 45-year-old women undergo a triple screening test: (1) two-view tomosynthesis of both breasts; (2) calculation of volumetric breast density (VBD); (3) assessment of breast cancer risk using the Tyrer-Cuzick model. Mean VBD and lifetime risk (LTR) are used to determine the type of imaging and frequency of subsequent screening cycles. |
Who may qualify
- Ages
- 45 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- Aged 45 years old
- Resident in the provinces of Padua and Rovigo (Italy)
- Willing and able to give written informed consent
- Willing and able to comply with scheduled visits, tests, and other procedures
Key exclusion criteria (7 listed)
- Recent mammography
- Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS)
- Known BRCA carrier or PALB2 or ≥50% risk
- Psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up
- Pregnant or breastfeeding
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 |
|---|---|---|
| Personalized screening protocolAt the first screening round (recruitment) all participating women had the same tests; * Two-view tomosynthesis of both breasts * Calculation of volumetric breast density (VBD) * Calculation of lifetime risk (LTR) using the Tyrer-Cuzick model At subsequent rounds: 1. Women with non-dense breasts and low breast cancer risk are re-screened only with DBT every 2 years; 2. Women with dense breasts and low breast cancer risk are re-screened with DBT+US every 2 years; 3. Women with non-dense breasts and intermediate breast cancer risk are re-screened only with DBT every year; 4. Women with dense breasts and intermediate breast cancer risk are re-screened with DBT+US every year; 5. Women at high risk of breast cancer associated with a family history of breast cancer (w/wo hereditary factors) undergo DBT and MRI every year. | Diagnostic test | RIBBS arm |
Primary outcome
Cumulative Incidence of Advanced Cancers
Time frame: Up to 15 years
Percentage of breast cancer cases diagnosed at staged II or beyond, either during the entire screening period or thereafter. Advanced cancers occurring up to 10 years after the end of the screening intervention will be included
9 secondary outcomes
Recall rate (RR)
Time frame: Up to 6 years
Cancer detection rate (CDR)
Time frame: Up to 6 years
Proportional Incidence of Interval Cancer
Time frame: Up to 8 years
Total Assessment Rate
Time frame: Up to 6 years
Surgical Referral Rate
Time frame: Up to 6 years
Surgery Rate
Time frame: Up to 6 years
Benign Lesion Detection Rate
Time frame: Up to 6 years
Tumor-Stage Specific Detection Rate
Time frame: Up to 6 years
Regular Re-Screening Rate
Time frame: Up to 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 40117106Caumo F, Gennaro G, Ravaioli A, Baldan E, Bezzon E, Bottin S, Carlevaris P, Ciampani L, Coran A, Dal Bosco C, Del Genio S, Dalla Pieta A, Falcini F, Maggetto F, Manco G, Masiero T, Petrioli M, Polico I, Pisapia T, Zemella M, Zorzi M, Zovato S, Bucchi L. Personalized screening based on risk and density: prevalence data from the RIBBS study. Radiol Med. 2025 May;130(5):740-752. doi: 10.1007/s11547-025-01981-5. Epub 2025 Mar 21.
- Derived from this study: PubMed 38512619Gennaro G, Bucchi L, Ravaioli A, Zorzi M, Falcini F, Russo F, Caumo F. The risk-based breast screening (RIBBS) study protocol: a personalized screening model for young women. Radiol Med. 2024 May;129(5):727-736. doi: 10.1007/s11547-024-01797-9. Epub 2024 Mar 21.
- Individual participant dataSharing planned: No
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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.
Francesca Caumo, MD principal investigator
Istituto Oncologico Veneto IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized screening protocol in people with Breast Neoplasms, run by Istituto Oncologico Veneto IRCCS 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 5 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: status not confirmed, as of the sponsor's last update on 12 Oct 2023. 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.
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?
Cumulative Incidence of Advanced Cancers (time frame: Up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05675085, which also lists 2 linked publications.
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 12 Oct 2023.