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Trial Title:
Risk-Based Breast Screening in Young Women
NCT ID:
NCT05675085
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Neoplasms
Cancer Screening
Personalized Medicine
Mammographic Breast Density
Risk Assessment
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Personalized screening protocol
Description:
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.
Arm group label:
RIBBS arm
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
Female
Gender based:
Yes
Minimum age:
45 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Istituto Oncologico Veneto (IRCCS)
Address:
City:
Padova
Zip:
35128
Country:
Italy
Start date:
January 20, 2020
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Istituto Oncologico Veneto IRCCS
Agency class:
Other
Collaborator:
Agency:
Regione del Veneto (Italy)
Agency class:
Other
Source:
Istituto Oncologico Veneto IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05675085