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IRIS: Risk-Based Imaging After Breast-Conserving Surgery

NCT07426510 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2300

Last updated 2026-02-23

No results posted yet for this study

Summary

Breast cancer follow-up after curative treatment is currently based on largely uniform imaging surveillance strategies, despite substantial variation in recurrence risk across patient subgroups. Early detection of recurrences improves prognosis, particularly when detected by imaging rather than symptoms, but the optimal surveillance approach remains uncertain. Mammographic sensitivity is lower in breast cancer survivors than in screening populations, and interval cancers occur more frequently, especially among younger patients, those with dense breasts, aggressive tumor subtypes, or without radiotherapy after breast-conserving surgery.

This multicenter, open-label, register-based randomized controlled trial evaluates risk-stratified imaging surveillance after breast-conserving surgery for breast cancer. The study investigates whether more sensitive imaging methods, compared with standard mammographic follow-up, lead to earlier detection of ipsilateral recurrences and contralateral second primary breast cancers in patients at increased risk of recurrence.

The primary endpoint is the number of interval ipsilateral recurrences and contralateral second primary breast cancers detected within five years from index diagnosis. Secondary endpoints include stage at detection, breast cancer-specific survival, overall survival, recall rate, biopsy rate, false positive findings, and health-related quality of life.

Conditions

Interventions

DIAGNOSTIC_TEST

Risk-Stratified Imaging Surveillance

Surveillance using more sensitive breast imaging modalities such as MRI or contrast-enhanced mammography based on recurrence risk.

DIAGNOSTIC_TEST

Standard Mammographic Surveillance

Routine follow-up with mammography according to current clinical guidelines.

Sponsors & Collaborators

  • Umeå University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2034-01-31
Completion
2034-01-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07426510 on ClinicalTrials.gov