Breast CancerPhase 3NCT07357298
Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer
A Phase 3 study testing Surveillance Brain MRI in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Surveillance Brain MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Feb 2026to Feb 2030
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
- Radiographic evidence of stage IV extracranial disease enrolled within 60 days of diagnosis or starting first line therapy. HR+/HER2- patients may be enrolled within 60 days of starting 2nd line therapy as well.
- HR+ will be defined as ER and/or PR > 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines41. Triple negative will be classified as ER and PR <10% and HER2-.
- Age ≥ 18
- Life expectancy ≥ 6 months
- Eastern Cooperative Oncology Group performance status ≤ 2
- Patients must be able to understand and the willingness to sign an informed consent for study procedures
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- Prior diagnosis or treatment of brain metastases or leptomeningeal disease
- History of other non-breast malignancy requiring treatment with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of > 90%), such as but not limited to, non-melanoma skin cancers, stage I endometrioid uterine cancer, and others at the discretion of the PI
- Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
- Indications warranting brain MRI for other neurologic conditions at time of study entry (including multiple sclerosis, stroke, traumatic brain injuries, epilepsy, hydrocephalus and pituitary gland disorders)
- Contraindication towards MRI with contrast
- Chronic kidney disease stage IV or V or end stage renal disease (CrCl <30 ml/min)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Baptist Health South Florida
Miami, Florida, 33176
Rupesh Kotecha, MD
Reshma Mahtani, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Kamran Ahmed, MD
About this study
This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Patients are stratified by receptor subtype, age, prior therapy, and study site, then randomized 1:1 to either scheduled surveillance MRIs or standard-of-care symptom-triggered imaging. The study aims to determine whether earlier detection leads to differences in treatment modality, frequency of brain metastases, leptomeningeal disease incidence, quality of life, and survival outcomes.
- Conditions
- Breast Cancer
- Being tested
- Surveillance Brain MRI, Standard of Care Brain Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveillance Brain MRIDiagnostic test
Routine scheduled MRI imaging at baseline and at 6-month intervals.
Standard of Care Brain ImagingDiagnostic test
Imaging performed only when clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Surveillance Brain MRI | Other | Participants receive a baseline brain MRI followed by surveillance brain MRI every 6 months for 24 months. Receives: Diagnostic Test: Surveillance Brain MRI |
| Standard of Care Brain Imaging | Other | Participants receive a baseline brain MRI followed by standard-of-care imaging only if neurologic symptoms develop. Receives: Diagnostic Test: Standard of Care Brain Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Characteristics of Brain Metastases
Proportion of patients receiving surgery or whole-brain radiation therapy for brain metastases.
Measured: Up to 24 Months
Secondary outcomes (6)
Frequency of Brain Metastases
The frequency of metastasis detection over the 24-month screening/follow-up period.
Measured: Up to 24 Months
Leptomeningeal Disease Incidence
Incidence of radiographic detection of leptomeningeal disease.
Measured: Up to 24 Months
Brain Metastases at Diagnosis
Average number of lesions on diagnostic MRI.
Measured: Up to 24 Months
Size of Largest Brain Metastasis
Average size of largest brain metastasis.
Measured: Up to 24 Months
Overall Survival After Brain Metastasis Diagnosis
Time from brain metastasis diagnosis to death from any cause.
Measured: Up to 48 Months
Brain Metastasis Specific Survival
Time from brain metastasis diagnosis to death attributable to brain metastases.
Measured: Up to 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start25 Feb 2026
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (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 H. Lee Moffitt Cancer Center and Research InstituteThe 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 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health, Florida Biomedical Research Program - Bankhead Coley
- Responsible party
- Sponsor
- Investigators
- Kamran Ahmed, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357298
- Sponsor's protocol ID
- MCC-24030
- Status last verified
- May 2026
- First submitted
- 12 Jan 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer
- ClinicalTrials.gov ID
- NCT07357298
- Acronym / sponsor ID
- MCC-24030
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Florida Department of Health, Florida Biomedical Research Program - Bankhead Coley
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 22 Jan 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.
This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Patients are stratified by receptor subtype, age, prior therapy, and study site, then randomized 1:1 to either scheduled surveillance MRIs or standard-of-care symptom-triggered imaging. The study aims to determine whether earlier detection leads to differences in treatment modality, frequency of brain metastases, leptomeningeal disease incidence, quality of life, and survival outcomes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surveillance Brain MRI | Other | Diagnostic Test: Surveillance Brain MRIParticipants receive a baseline brain MRI followed by surveillance brain MRI every 6 months for 24 months. |
| Standard of Care Brain Imaging | Other | Diagnostic Test: Standard of Care Brain ImagingParticipants receive a baseline brain MRI followed by standard-of-care imaging only if neurologic symptoms develop. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
- Radiographic evidence of stage IV extracranial disease enrolled within 60 days of diagnosis or starting first line therapy. HR+/HER2- patients may be enrolled within 60 days of starting 2nd line therapy as well.
- HR+ will be defined as ER and/or PR > 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines41. Triple negative will be classified as ER and PR <10% and HER2-.
- Age ≥ 18
- Life expectancy ≥ 6 months
Key exclusion criteria (6 listed)
- Prior diagnosis or treatment of brain metastases or leptomeningeal disease
- History of other non-breast malignancy requiring treatment with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of > 90%), such as but not limited to, non-melanoma skin cancers, stage I endometrioid uterine cancer, and others at the discretion of the PI
- Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
- Indications warranting brain MRI for other neurologic conditions at time of study entry (including multiple sclerosis, stroke, traumatic brain injuries, epilepsy, hydrocephalus and pituitary gland disorders)
- Contraindication towards MRI with contrast
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 |
|---|---|---|
| Surveillance Brain MRIRoutine scheduled MRI imaging at baseline and at 6-month intervals. | Diagnostic test | Surveillance Brain MRI |
| Standard of Care Brain ImagingImaging performed only when clinically indicated. | Diagnostic test | Standard of Care Brain Imaging |
Primary outcome
Treatment Characteristics of Brain Metastases
Time frame: Up to 24 Months
Proportion of patients receiving surgery or whole-brain radiation therapy for brain metastases.
6 secondary outcomes
Frequency of Brain Metastases
Time frame: Up to 24 Months
Leptomeningeal Disease Incidence
Time frame: Up to 24 Months
Brain Metastases at Diagnosis
Time frame: Up to 24 Months
Size of Largest Brain Metastasis
Time frame: Up to 24 Months
Overall Survival After Brain Metastasis Diagnosis
Time frame: Up to 48 Months
Brain Metastasis Specific Survival
Time frame: Up to 48 Months
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 15 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Kamran Ahmed, MD principal investigator
Moffitt Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surveillance Brain MRI in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
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 8 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: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rheese McNab (813-745-1780, Rheese.McNab@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Characteristics of Brain Metastases (time frame: Up to 24 Months). 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 15 May 2026.