Tomosynthesis as Primary Test for Breast Cancer Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2029-04-30

Brief Summary

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Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers.

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Detailed Description

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This is a companion study of the other Italian studies on tomosyntesis as primary screening test for breast cancer: RETomo (NCT02698202), PROTEUS (NCT02590315), IMPETO (NCT03587259). The investigators conduct a randomized trial in three centres with a protocol that is similar to that of the other three studies. As for IMPETO and differently from the RETomo and PROTEUS studies, the intervention will be tomosynthesis + synthetic 2D.

In the three centres about 8000 women will be recruited (4000 in the experimental arm and 4000 in the control arm).

The study will compare the performance of tomosynthesis plus synthetic 2D vs digital mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers. Women 50 to 65 years old will be screened once according to randomization arm for one round, then all will be screened with digital mammography after two years.

The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate excess overdiagnosis comparing overall cumulative incidence after two or three rounds of screening.

Women will be asked for informed consent when they attend the mammography. If they accept they will be randomised to one of the two arms.

All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Women 45-65 participating in the mammographic screening program will be randomized to one round of screening with tomosynthesis + synthetic 2D or with digital mammography. Then all women will be re-screened after 2 years (1 year for women 45-49) for at least one round with digital mammography.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

It is not possible to mask the intervention for the patient, care provider, and investigator.

Only the assessment of one of the two co-primary outcomes, i.e. cumulative incidence of advanced breast cancer after the first round of screening, can be masked. This will be obtained through a blind review of an external panel of pathologists and radiologists reviewing cases retrieved by cancer registries.

Study Groups

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Tomosynthesis + synthetic 2D

Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.

After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Group Type EXPERIMENTAL

tomosynthesis + synthetic 2D

Intervention Type DIAGNOSTIC_TEST

Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.

After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Digital Mammography

Women will be screened for digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.

After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Group Type ACTIVE_COMPARATOR

digital mammography

Intervention Type DIAGNOSTIC_TEST

Women will be screened for one round digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.

After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Interventions

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tomosynthesis + synthetic 2D

Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.

After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Intervention Type DIAGNOSTIC_TEST

digital mammography

Women will be screened for one round digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.

After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Women scheduled for a new round of mammographic screening
* resident in the province

Exclusion Criteria

* previous breast cancer diagnosis
* pregnancy or suspicion of pregnancy
* presence of BRCA1/2 gene mutation
* Previous Digital Breast Tomosynthesis performed
* unable to understand informed consent
* chemotherapy in progress
* presence of breast implant

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes