Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether brain MRI scans every 6 months help find and treat breast cancer that has spread to the brain sooner than scans done only when symptoms appear. It is for adults with stage IV breast cancer who have no brain or nerve symptoms. Patients are placed by chance into one of the two scan groups.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Have breast cancer confirmed by a tissue test, with ER, PR, and HER2 test results recorded. These tests show the cancer’s hormone and protein markers.
- Have scans showing stage IV cancer that has spread outside the breast to areas outside the brain. Join within 60 days of diagnosis or starting the first course of treatment.
- If the cancer is hormone receptor-positive and HER2-negative, you may also join within 60 days of starting the second course of treatment.
- Be expected to live at least 6 months.
- Be able to care for yourself and be out of bed or a chair for more than half of your waking hours, even if you cannot work.
- Be able to understand the study and willing to sign a consent form.
- Be willing to follow all study steps and be available for the full study.
Who can't join
- Have ever been diagnosed with or treated for cancer spread to the brain or the tissue and fluid around the brain and spinal cord.
- Have a history of another cancer that needs treatment, unless it has a very low risk of spreading or causing death. The study doctor may allow some cancers.
- Have brain or nerve symptoms that your doctor thinks need a brain MRI when you join.
- Need a brain MRI for another condition when you join, such as multiple sclerosis, stroke, brain injury, seizures, fluid buildup in the brain, or pituitary gland problems.
- Cannot safely have an MRI with contrast, a substance used to make the pictures clearer.
- Have severe kidney disease: stage IV or V, end-stage kidney disease, or kidney filtering below 30 mL per minute.
Simplified for readability. The official criteria below are what the study team uses.
Official 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)
Study sites (2)
FL
- Baptist Health South Florida · Miami, FL 33176Rupesh Kotecha, MD · Principal investigatorReshma Mahtani, MD · Principal investigatorMore trials in Miami
- Moffitt Cancer Center · Tampa, FL 33612Kamran Ahmed, MD · Principal investigatorMore trials in Tampa