NCT06270355

Brief Summary

SMART is a Phase III, randomised, non-blinded screening trial. Women who consent to participate in SMART are randomised to either individualised screening or screening according to the Swedish National Breast Cancer Screening Program. Women randomised to individualised screening get their 2-year risk of breast cancer assessed and women with the highest short-term risk are offered contrast enhanced mammography and a mammogram at 12 months.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70,000

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
71mo left

Started Apr 2024

Typical duration for phase_3 breast-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Apr 2024Apr 2032

First Submitted

Initial submission to the registry

December 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 8, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2028

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2032

Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4 years

First QC Date

December 19, 2023

Last Update Submit

February 26, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of interval cancers

    For women at high 2-year risk in the intervention arm interval cancers are defined as cancers diagnosed in the interval between CEM and 12-month mammogram plus in the interval between 12- and 24-month interval. For the remaining women in the trial interval cancers are defined as cancers diagnosed between baseline mammography and 24-month mammography.

    24-month

Secondary Outcomes (1)

  • Number of recalled women

    24-month

Other Outcomes (11)

  • Number of biopsies

    24-month

  • Breast cancer

    24-month

  • Tumor characteristics - Stage

    24-month

  • +8 more other outcomes

Study Arms (2)

Experimental arm

EXPERIMENTAL

Women randomised to the experimental arm / individualised screening will have their 2-year breast cancer risk assessed upfront. This is done via an AI (artificial intelligence) derived analyses of the mammograms. Women scored with the highest 2-year risk will be offered a contrast enhanced mammography and an additional mammography at 12 months.

Procedure: Risk based screening

No intervention arm

ACTIVE COMPARATOR

The 35,000 women randomised to the no intervention arm will continue in the Swedish National Breast Cancer Screening Program. This means that they are invited for the next mammography screening after 24 months.

Procedure: Risk based screening

Interventions

Risk based screeningPROCEDURE

Women randomised to the individualised screening arm and judged to be at high risk will be invited to a contrast enhanced mammography and a mammography after 12 months. The intervention is thus a different selection of women compared to what is done today.

Experimental armNo intervention arm

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsRegistered as a woman in the Swedish social security number system.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have read, understood and signed the informed consent
  • Perform breast cancer screening at Södersjukhuset
  • Females in the age range 40 - 74 years at baseline mammography
  • Using a smartphone or tablet with BankID

You may not qualify if:

  • Pregnant, breast feeding or planning to become pregnant.
  • Previous breast cancer
  • A medical condition that according to the responsible physician would negatively affect the health of the women.
  • Cognitive impairment and / or language ability that would make it difficult for the participant to understand the implication of study and to perform a contrast mammography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Per Hall, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Per Hall, Professor

CONTACT

+46 8-524 823 39per.hall@ki.se

Mattias Hammarström, CTM

CONTACT

+46 737121476mattias.hammarstrom@ki.se

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, MD

Study Record Dates

First Submitted

December 19, 2023

First Posted

February 21, 2024

Study Start

April 8, 2024

Primary Completion (Estimated)

April 8, 2028

Study Completion (Estimated)

April 8, 2032

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share