Clinical trial NCT02210546: Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk
Official title: A Multicenter Randomised Trial of Contrast-enhanced MR Imaging as a Breast Cancer Screening Tool Alternative to Mammography and Ultrasonography in Women at Intermediate Risk. Feasibility, and Short Term Results.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
intermediate risk
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of in situ and invasive breast cancers detected in the two arms of the study
timeFrame: 36 months
Secondary outcomes:
measure: Number of patients per each clinical and pathological stage of invasive cancer detected in the two arms of the study
timeFrame: 3 years
measure: Proportion of the different histological characteristics of cancers detected in the two arms
timeFrame: 3 years
measure: Number of invasive diagnostic procedures in the two study arms.
timeFrame: 3 years
measure: Number of interval cancers in the two study arms.
timeFrame: 3 years
measure: Rate of eligible women who accept to enter the study.
timeFrame: 3 years
measure: Compliance to the intervention in the two study arms.
timeFrame: 3 years
measure: Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms
timeFrame: 3 years
measure: 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
timeFrame: 10 years
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria S.Martino IST
Study officials:
affiliation: Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples)
name: Antonella Petrillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Gemelli (Rome)
name: Paolo Belli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale san Raffaele (Milan)
name: Alessandro Del Maschio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Candiolo (Turin)
name: Laura Martincich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AOU S.Maria della Misericordia (Udine)
name: Massimo Bazzocchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori (Milan)
name: Piero Panizza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Stefania Montemezzi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Policlinico Umberto I (Rome)
name: Federica Pediconi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliero Universitaria (Ferrara)
name: Stefano Corcione, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS AOU S. Martino-IST (Genoa)
name: Massimo Calabrese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Donato (Milan)
name: Francesco Sardanelli, MD
role: PRINCIPAL_INVESTIGATOR
References: