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Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surveillance Brain MRI

    Diagnostic test

    Routine scheduled MRI imaging at baseline and at 6-month intervals.

  • Standard of Care Brain Imaging

    Diagnostic test

    Imaging performed only when clinically indicated.

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Surveillance Brain MRIOther 1 intervention
Group B: Standard of Care Brain ImagingOther 1 intervention

Trial outcomes

Primary outcomes

1

Treatment Characteristics of Brain Metastases

Proportion of patients receiving surgery or whole-brain radiation therapy for brain metastases.

Time frame
Up to 24 Months

Secondary outcomes

1

Frequency of Brain Metastases

The frequency of metastasis detection over the 24-month screening/follow-up period.

Time frame
Up to 24 Months
2

Leptomeningeal Disease Incidence

Incidence of radiographic detection of leptomeningeal disease.

Time frame
Up to 24 Months
3

Brain Metastases at Diagnosis

Average number of lesions on diagnostic MRI.

Time frame
Up to 24 Months
4

Size of Largest Brain Metastasis

Average size of largest brain metastasis.

Time frame
Up to 24 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Florida Department of Health

Collaborator

Florida Biomedical Research Program - Bankhead Coley

Collaborator

Source ClinicalTrials.gov
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