IRIS: Risk-Based Imaging After Breast-Conserving Surgery

NCT07426510 | Not Yet Recruiting

• 1 other identifier: Swe-BC-IRIS2026
• Study Type: interventional
• Target: 2,300
• Locations: 0 countries
• Sites: N/A

Brief 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

Breast Cancer

Keywords

Breast cancer; Imaging surveillance; Recurrence detection; Risk-stratified follow-up; MRI breast; Register-based randomized trial

Outcome Measures

Primary Outcomes (1)

• Interval Ipsilateral Recurrences and Contralateral Second Primary Breast Cancers

  Number of ipsilateral breast cancer recurrences and contralateral second primary breast cancers detected between scheduled surveillance examinations.

  From index breast cancer diagnosis up to 5 years

Secondary Outcomes (7)

• Stage at Diagnosis of Recurrences and Second Primary Breast Cancers

  Up to 5 years from index diagnosis

• Breast Cancer-Specific Survival

  Up to 5 years from index diagnosis

• Overall Survival

  Up to 5 years from index diagnosis

• Recall Rate

  During the 5-year surveillance period

• Biopsy Rate

  During the 5-year surveillance period

Study Arms (2)

Risk-Stratified Imaging Surveillance

EXPERIMENTAL

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.

Diagnostic Test: Risk-Stratified Imaging Surveillance

Standard Mammographic Surveillance

ACTIVE COMPARATOR

Participants receive standard post-treatment imaging surveillance with mammography according to current clinical follow-up guidelines after breast-conserving surgery.

Diagnostic Test: Standard Mammographic Surveillance

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.

Risk-Stratified Imaging Surveillance

Standard Mammographic Surveillance DIAGNOSTIC_TEST

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

Standard Mammographic Surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed primary breast cancer
• Treated with breast-conserving surgery with curative intent
• Completed primary treatment according to clinical guidelines
• Classified as having increased risk of recurrence according to predefined study risk criteria (based on factors such as age, tumor subtype)
• Eligible for imaging surveillance
• Registered in participating national or regional breast cancer registry
• Able to comply with study follow-up procedures

You may not qualify if:

• Previous ipsilateral or contralateral invasive breast cancer within the last 5 years (except index cancer)
• Bilateral mastectomy
• Known metastatic breast cancer at time of enrollment
• Contraindication to contrast agents or MRI (if applicable for assigned arm)
• Ongoing pregnancy at time of randomization
• Any condition that, in the investigator's judgment, prevents participation in imaging surveillance

Sponsors & Collaborators

• Umeå University: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Charlotta Wadsten, Assoc Prof, MD

CONTACT

+4660181000; charlotta.wadsten@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 23, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2034
• Last Updated: February 23, 2026

Record last verified: 2026-02