IRIS: Risk-Based Imaging After Breast-Conserving Surgery

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Risk-Stratified Imaging Surveillance — DIAGNOSTIC_TEST
  Surveillance using more sensitive breast imaging modalities such as MRI or contrast-enhanced mammography based on recurrence risk.
• Standard Mammographic Surveillance — DIAGNOSTIC_TEST
  Routine follow-up with mammography according to current clinical guidelines.

Study Details

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.

Key Dates

First listed

Feb 23, 2026

Start date

Aug 31, 2026

Status verified

Feb 2026

Primary completion

Jan 31, 2034

Completion

Jan 31, 2034

Study Design

Enrollment

2,300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Risk-Stratified Imaging Surveillance
  Participants receive risk-stratified post-treatment imaging surveillance using more sensitive imaging modalities (such as MRI or contrast-enhanced mammography) according to predefined risk criteria, instead of standard mammographic follow-up.
• Active Comparator: Standard Mammographic Surveillance
  Participants receive standard post-treatment imaging surveillance with mammography according to current clinical follow-up guidelines after breast-conserving surgery.

Primary Outcome Measure

Interval Ipsilateral Recurrences and Contralateral Second Primary Breast Cancers [ Time Frame: From index breast cancer diagnosis up to 5 years ]

Central Contacts

• Charlotta Wadsten, Assoc Prof, MD
  +4660181000
  [email protected]

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