Breast Cancer
Conditions
Keywords
breast cancer, intermediate risk
Brief summary
A multicenter randomized controlled trial to evaluate the performance of MRI, in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer. Two surveillance programs will be compared. Women will be randomly assigned with a 1:1 ratio to: 1. Yearly two-view mammography (Mx) and breast ultrasonography (US) or 2. Yearly MRI.
Detailed description
Women, who, due to an increased risk of invasive breast cancer, are offered a specific surveillance program, as a supplement to the standard screening activities which in Italy are based on mammography every two years starting at age 50.Women will be randomly assigned to Yearly two-view mammography (Mx) and breast ultrasonography (US) or to Yearly MRI.
Interventions
OTHERMagnetic Resonance Imaging (MRI)
OTHERMammography (Mx) + ultrasonography (US)
Sponsors
Prof. Paolo Bruzzi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 40-59 years with * cumulative risk at 10 years of at least 5%, or a lifetime cumulative breast cancer risk ranging between 15% and 30% (equivalent to a relative risk of 2-6 as compared to a low risk woman of the same age). The lifetime cumulative risk of breast cancer will be computed using the IBIS Breast Cancer Risk Evaluation Tool (http://www.ems-trials.org/riskevaluator/); or mammographic density involving more than 75% of the breast area, based on the most recent mammogram. The evaluation of the composition of the mammary gland will be performed using the BI-RADS classification. Women with mammography in class 4 (i.e., \>75% of glandular component) will be eligible for randomization. * Written Informed consent
Exclusion criteria
* Signs or symptoms of breast cancer at enrolment; * Previous diagnosis of ductal carcinoma in situ or invasive breast cancer; * BRCA or p53 mutation carrier status; * General contraindications to MRI (e.g. cardiac pacemaker, metal implants or history of severe allergic reaction after administration of contrast agent; * Contraindications to any intravenous administration of contrast agent; * Ongoing or planned pregnancy (for the duration of the study); * Hormonal enhancement of ovarian function for assisted reproduction in the previous 3 years * Presence of breast implants; * Previous diagnosis of cancer at any site; * Life-threatening diseases; * Mental disability precluding informed consent to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of in situ and invasive breast cancers detected in the two arms of the study | 36 months | The performance of MRI will be evaluated , in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of the different histological characteristics of cancers detected in the two arms | 3 years |
| Number of invasive diagnostic procedures in the two study arms. | 3 years |
| Number of interval cancers in the two study arms. | 3 years |
| Number of patients per each clinical and pathological stage of invasive cancer detected in the two arms of the study | 3 years |
| Compliance to the intervention in the two study arms. | 3 years |
| Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms | 3 years |
| Number of cancers (in situ and invasive) detected in excess in the experimental arm compared to the conventional arm (overdiagnosis) after 10 years of follow up | 10 years |
| Rate of eligible women who accept to enter the study. | 3 years |
Countries
Italy
Contacts
Primary ContactPaolo Bruzzi, MD
Outcome results
None listed