NCT07357298 Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer
| NCT ID | NCT07357298 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2026-02-25 |
| Primary Completion | 2030-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 156 participants in total. It began in 2026-02-25 with a primary completion date of 2030-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Contact & Investigator
Kamran Ahmed, MD
PRINCIPAL INVESTIGATOR
Moffitt Cancer Center
Frequently Asked Questions
Who can join the NCT07357298 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07357298 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 156 participants.
Is NCT07357298 currently recruiting?
Yes, NCT07357298 is actively recruiting participants. Contact the research team at Rheese.McNab@moffitt.org for enrollment information.
Where is the NCT07357298 trial being conducted?
This trial is being conducted at Miami, United States, Tampa, United States.
Who is sponsoring the NCT07357298 clinical trial?
NCT07357298 is sponsored by H. Lee Moffitt Cancer Center and Research Institute. The principal investigator is Kamran Ahmed, MD at Moffitt Cancer Center. The trial plans to enroll 156 participants.
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