Breast Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTSurveillance Brain MRI
Routine scheduled MRI imaging at baseline and at 6-month intervals.
DIAGNOSTIC_TESTStandard of Care Brain Imaging
Imaging performed only when clinically indicated.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Florida Department of Health
Florida Biomedical Research Program - Bankhead Coley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Characteristics of Brain Metastases | Up to 24 Months | Proportion of patients receiving surgery or whole-brain radiation therapy for brain metastases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Brain Metastases | Up to 24 Months | The frequency of metastasis detection over the 24-month screening/follow-up period. |
| Leptomeningeal Disease Incidence | Up to 24 Months | Incidence of radiographic detection of leptomeningeal disease. |
| Brain Metastases at Diagnosis | Up to 24 Months | Average number of lesions on diagnostic MRI. |
| Size of Largest Brain Metastasis | Up to 24 Months | Average size of largest brain metastasis. |
| Overall Survival After Brain Metastasis Diagnosis | Up to 48 Months | Time from brain metastasis diagnosis to death from any cause. |
| Brain Metastasis Specific Survival | Up to 48 Months | Time from brain metastasis diagnosis to death attributable to brain metastases. |
Countries
United States
Contacts
CONTACTRheese McNab
PRINCIPAL_INVESTIGATORKamran Ahmed, MD
Moffitt Cancer Center
Outcome results
None listed