IRIS: Risk-Based Imaging After Breast-Conserving Surgery
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUmeå University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Risk-Stratified Imaging Surveillance
Diagnostic testSurveillance using more sensitive breast imaging modalities such as MRI or contrast-enhanced mammography based on recurrence risk.
Standard Mammographic Surveillance
Diagnostic testRoutine follow-up with mammography according to current clinical guidelines.
Treatment groups
2,300 Participants
are divided into 2 treatment groupsGroup A: Risk-Stratified Imaging SurveillanceExperimental treatment 1 intervention
Group B: Standard Mammographic SurveillanceActive comparator 1 intervention
Trial outcomes
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.
Time frame
From index breast cancer diagnosis up to 5 yearsSecondary outcomes
1
Stage at Diagnosis of Recurrences and Second Primary Breast Cancers
Tumor stage at diagnosis of ipsilateral recurrences and contralateral second primary breast cancers
Time frame
Up to 5 years from index diagnosis2
Breast Cancer-Specific Survival
Survival without death attributed to breast cancer
Time frame
Up to 5 years from index diagnosis3
Overall Survival
Survival from any cause
Time frame
Up to 5 years from index diagnosis4
Recall Rate
Proportion of surveillance examinations leading to recall for additional diagnostic assessment
Time frame
During the 5-year surveillance periodLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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