๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-14

Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer (NCT07357298)

๐ŸŸข Recruiting Phase3 ๐Ÿ“‹ Clinical Research Protocol Sponsor: H. Lee Moffitt Cancer Center and Research Institute

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Baptist Health South Florida โ€” Miami, Florida

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • Surveillance Brain MRI (DIAGNOSTIC_TEST)
  • Standard of Care Brain Imaging (DIAGNOSTIC_TEST)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • Baptist Health South Florida โ€” Miami, Florida
  • Moffitt Cancer Center โ€” Tampa, Florida

๐Ÿ“ž Contact the Study Coordinator

Phone: (813) 745-1780

Email: Rheese.McNab@moffitt.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Breast Cancer clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—