Clinical trial NCT04461808: Tomosynthesis as Primary Test for Breast Cancer Screening
Official title: Tomosynthesis as Primary Test for Breast Cancer Screening: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer screening
tomosynthesis
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
Collaborators: name: AULSS 9 Scaligera di Verona
name: IRCCS Policlinico S. Donato, Milano
name: Azienda Ospedaliera Universitaria Integrata Verona
First posted: 2020-07-08
Enrollment: 10156
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: advanced cancer incidence
timeFrame: 2 years (+9 months to complete second round assessment)
measure: advanced cancer incidence
timeFrame: 4 years (+9 months to complete third round assessment)
measure: interval cancer incidence
timeFrame: 2 years for 50-65 years old women
measure: interval cancer incidence
timeFrame: 1 year for 45-49 years old women
Secondary outcomes:
measure: overall cumulative incidence
timeFrame: 2 years (+9 months to complete second round assessment)
measure: overall cumulative incidence
timeFrame: 4 years (+9 months to complete second round assessment)
measure: detection rate
timeFrame: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
measure: recall rate
timeFrame: This outcome is measured at the baseline screening.
measure: positive predictive value
timeFrame: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
measure: Detection rate of ductal carcinoma in situ
timeFrame: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
measure: biopsy rate
timeFrame: This outcome is measured at the baseline screening.
measure: x-ray dose
timeFrame: This outcome is measured at the baseline screening.
measure: reading time
timeFrame: This outcome is measured at the baseline screening.
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Policlinico San Donato
city: Reggio Emilia
country: Italy
facility: Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata
city: Verona
country: Italy
facility: Azienda Ulss 9 Scaligera
Study officials:
References: