Risk-Based Breast Screening in Young Women

NCT05675085 | Unknown

• 1 other identifier: RIBBS 2019/37
• Study Type: interventional
• Target: 10,269
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Breast Neoplasms

Keywords

Breast Neoplasms; Cancer Screening; Personalized Medicine; Mammographic Breast Density; Risk Assessment

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 15 years

Secondary Outcomes (9)

• Recall rate (RR)

  Up to 6 years

• Cancer detection rate (CDR)

  Up to 6 years

• Proportional Incidence of Interval Cancer

  Up to 8 years

• Total Assessment Rate

  Up to 6 years

• Surgical Referral Rate

  Up to 6 years

Other Outcomes (6)

• Cost and Organizational Impact Analysis

  Up to 8 years

• Impact of Breast Cancer Risk Model on Personalization of Screening

  Up to 8 years

• Impact of Breast Density Metrics on Personalization of Screening

  Up to 8 years

Study Arms (1)

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.

Diagnostic Test: Personalized screening protocol

Interventions

Personalized screening protocol DIAGNOSTIC_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: 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.

RIBBS arm

Eligibility Criteria

• Age: 45 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead
• Regione del Veneto (Italy): collaborator

Study Sites (1)

Istituto Oncologico Veneto (IRCCS)

Padua, 35128, Italy

Location

Related Publications (2)

• 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.

  PMID: 40117106 DERIVED

• Gennaro 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.

  PMID: 38512619 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Francesca Caumo, MD

  Istituto Oncologico Veneto IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: January 9, 2023
• Study Start: January 20, 2020
• Primary Completion: December 21, 2021
• Study Completion: January 31, 2026
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)