Breast CancerIRISNCT07426510
IRIS: Risk-Based Imaging After Breast-Conserving Surgery
A study testing Risk-Stratified Imaging Surveillance and Standard Mammographic Surveillance in people with Breast Cancer, run by Umeå University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Risk-Stratified Imaging Surveillance and Standard Mammographic Surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jan 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Individualized Riskbased Imaging Surveillance After Breast-conserving Surgery for Breast Cancer (IRIS)- a Multicenter Randomized 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.
Read the detailed description
The effectiveness of current breast cancer follow-up guidelines after curative treatment remains uncertain. Although early detection of local recurrences is associated with improved survival, particularly when identified through imaging rather than symptoms, evidence supporting the optimal intensity and modality of post-treatment surveillance is limited. Current follow-up recommendations are largely uniform, despite well-established variation in recurrence risk related to age, tumor subtype, surgical margins, adjuvant therapy, and breast density. Younger patients and those with non-luminal tumor subtypes have a substantially higher risk of recurrence.
Mammographic sensitivity is lower in breast cancer survivors compared with screening populations, and the incidence of interval cancers is significantly higher. Risk factors for interval-detected recurrences include young age, dense breast tissue, omission of radiotherapy after breast-conserving surgery, and biologically aggressive tumors. Supplemental imaging modalities such as magnetic resonance imaging (MRI) and contrast-enhanced mammography (CEM) have shown higher sensitivity and may improve detection in higher-risk groups, but current evidence is insufficient to support broad implementation of risk-based surveillance strategies.
This study is a multicenter, open-label, register-based randomized controlled trial designed to evaluate a stratified imaging surveillance approach after curative treatment for breast cancer. The objective is to determine whether the use of more sensitive imaging methods, compared with standard mammographic surveillance, results in earlier detection of ipsilateral recurrences and contralateral second primary breast cancers in patients with increased risk of recurrence following breast-conserving surgery.
The primary endpoint is the number of interval-detected ipsilateral recurrences and contralateral second primary breast cancers within five years from index breast cancer diagnosis. Secondary endpoints include stage at diagnosis, breast cancer-specific survival, overall survival, recall rate, biopsy rate, number of false positive findings, and health-related quality of life.
- Conditions
- Breast Cancer
- Being tested
- Risk-Stratified Imaging Surveillance, Standard Mammographic Surveillance
- Keywords
- Breast cancer, Imaging surveillance, Recurrence detection, Risk-stratified follow-up, MRI breast, Register-based randomized trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-Stratified Imaging SurveillanceDiagnostic test
Surveillance using more sensitive breast imaging modalities such as MRI or contrast-enhanced mammography based on recurrence risk.
Standard Mammographic SurveillanceDiagnostic test
Routine follow-up with mammography according to current clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Standard Mammographic Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From index breast cancer diagnosis up to 5 years
Secondary outcomes (7)
Stage at Diagnosis of Recurrences and Second Primary Breast Cancers
Tumor stage at diagnosis of ipsilateral recurrences and contralateral second primary breast cancers
Measured: Up to 5 years from index diagnosis
Breast Cancer-Specific Survival
Survival without death attributed to breast cancer
Measured: Up to 5 years from index diagnosis
Overall Survival
Survival from any cause
Measured: Up to 5 years from index diagnosis
Recall Rate
Proportion of surveillance examinations leading to recall for additional diagnostic assessment
Measured: During the 5-year surveillance period
Biopsy Rate
Number of biopsies performed following surveillance imaging
Measured: During the 5-year surveillance period
False Positive Findings
Number of surveillance findings leading to diagnostic workup without cancer diagnosis
Measured: During the 5-year surveillance period
Health-Related Quality of Life
Measured using validated Patient-Reported Outcome Measures (PROM) questionnaires collected within the Swedish National Breast Cancer Quality Registry (Nationellt Kvalitetsregister för Bröstcancer).Patient-reported quality of life will be assessed using the EORTC QLQ-C30 (core cancer quality-of-life questionnaire) and the breast cancer-specific module QLQ-BR23, developed by the European Organisation for Research and Treatment of Cancer.Scores are calculated according to each instrument's scoring manual and transformed to standardized scales (0-100 or instrument-specific ranges). Higher scores indicate better function/global quality of life
Measured: Baseline (pre-treatment), 6 months, 12 months, and 3 years after diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study startAug 2026 (estimated)
- Primary completionJan 2034 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426510
- Sponsor's protocol ID
- Swe-BC-IRIS2026
- Acronym
- IRIS
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may be shared upon reasonable request and after approval by the study steering committee, in accordance with applicable regulations and data protection laws.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Riskbased Imaging Surveillance After Breast-conserving Surgery for Breast Cancer (IRIS)- a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT07426510
- Acronym / sponsor ID
- IRIS / Swe-BC-IRIS2026
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Imaging surveillance, Recurrence detection, Risk-stratified follow-up, MRI breast, Register-based randomized trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jan 2034 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The effectiveness of current breast cancer follow-up guidelines after curative treatment remains uncertain. Although early detection of local recurrences is associated with improved survival, particularly when identified through imaging rather than symptoms, evidence supporting the optimal intensity and modality of post-treatment surveillance is limited. Current follow-up recommendations are largely uniform, despite well-established variation in recurrence risk related to age, tumor subtype, surgical margins, adjuvant therapy, and breast density. Younger patients and those with non-luminal tumor subtypes have a substantially higher risk of recurrence.
Mammographic sensitivity is lower in breast cancer survivors compared with screening populations, and the incidence of interval cancers is significantly higher. Risk factors for interval-detected recurrences include young age, dense breast tissue, omission of radiotherapy after breast-conserving surgery, and biologically aggressive tumors. Supplemental imaging modalities such as magnetic resonance imaging (MRI) and contrast-enhanced mammography (CEM) have shown higher sensitivity and may improve detection in higher-risk groups, but current evidence is insufficient to support broad implementation of risk-based surveillance strategies.
This study is a multicenter, open-label, register-based randomized controlled trial designed to evaluate a stratified imaging surveillance approach after curative treatment for breast cancer. The objective is to determine whether the use of more sensitive imaging methods, compared with standard mammographic surveillance, results in earlier detection of ipsilateral recurrences and contralateral second primary breast cancers in patients with increased risk of recurrence following breast-conserving surgery.
The primary endpoint is the number of interval-detected ipsilateral recurrences and contralateral second primary breast cancers within five years from index breast cancer diagnosis. Secondary endpoints include stage at diagnosis, breast cancer-specific survival, overall survival, recall rate, biopsy rate, number of false positive findings, and health-related quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk-Stratified Imaging Surveillance | Experimental | Diagnostic Test: Risk-Stratified Imaging SurveillanceParticipants 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. |
| Standard Mammographic Surveillance | Active comparator | Diagnostic Test: Standard Mammographic SurveillanceParticipants receive standard post-treatment imaging surveillance with mammography according to current clinical follow-up guidelines after breast-conserving surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-Stratified Imaging SurveillanceSurveillance using more sensitive breast imaging modalities such as MRI or contrast-enhanced mammography based on recurrence risk. | Diagnostic test | Risk-Stratified Imaging Surveillance |
| Standard Mammographic SurveillanceRoutine follow-up with mammography according to current clinical guidelines. | Diagnostic test | Standard Mammographic Surveillance |
Primary outcome
Interval Ipsilateral Recurrences and Contralateral Second Primary Breast Cancers
Time frame: From index breast cancer diagnosis up to 5 years
Number of ipsilateral breast cancer recurrences and contralateral second primary breast cancers detected between scheduled surveillance examinations.
7 secondary outcomes
Stage at Diagnosis of Recurrences and Second Primary Breast Cancers
Time frame: Up to 5 years from index diagnosis
Breast Cancer-Specific Survival
Time frame: Up to 5 years from index diagnosis
Overall Survival
Time frame: Up to 5 years from index diagnosis
Recall Rate
Time frame: During the 5-year surveillance period
Biopsy Rate
Time frame: During the 5-year surveillance period
False Positive Findings
Time frame: During the 5-year surveillance period
Health-Related Quality of Life
Time frame: Baseline (pre-treatment), 6 months, 12 months, and 3 years after diagnosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data may be shared upon reasonable request and after approval by the study steering committee, in accordance with applicable regulations and data protection laws.
Related trials for Breast Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)
Not yet recruitingPhase 2
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
Breast Cancer, Advanced Breast Cancer
RecruitingObservational study
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Breast Cancer, Axillary Lymph Nodes Dissection
RecruitingPhase 2
A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Risk-Stratified Imaging Surveillance and Standard Mammographic Surveillance in people with Breast Cancer, run by Umeå University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotta Wadsten, Assoc Prof, MD (+4660181000, charlotta.wadsten@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interval Ipsilateral Recurrences and Contralateral Second Primary Breast Cancers (time frame: From index breast cancer diagnosis up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.