Recruiting
Phase 3

MRI

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT07357298

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surveillance Brain MRI

Standard of Care Brain Imaging

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT07357298

Start date

Feb 25, 2026

Status verified date

May, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Surveillance Brain MRI

Participants receive a baseline brain MRI followed by surveillance brain MRI every 6 months for 24 months.

other: Standard of Care Brain Imaging

Participants receive a baseline brain MRI followed by standard-of-care imaging only if neurologic symptoms develop.

Interventions

Surveillance Brain MRI

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

Standard of Care Brain Imaging

Imaging performed only when clinically indicated.

Primary outcome measure

  • Treatment Characteristics of Brain Metastases [ Time Frame: Up to 24 Months ]

Central Contacts and Locations

Central contacts

Rheese McNab

813-745-1780Rheese.McNab@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Kamran Ahmed, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-05-15.