Recruiting
Phase 2

Observational Study

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT05115474

Conditions

Triple Negative Breast Cancer

HER2-positive Breast Cancer

Hormone Receptor-positive Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Imaging

Study Details

Brief summary:

The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.

Conditions

Triple Negative Breast Cancer

HER2-positive Breast Cancer

Hormone Receptor-positive Breast Cancer

Study ID

NCT05115474

Start date

Dec 21, 2021

Status verified date

Sep, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun 16, 2026

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 diease having progressed past first line therapy in HR+/HER2- patients
  • Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients
  • Age ≥ 18
  • Life expectancy ≥ 6 months
  • Eastern Cooperative Oncology Group performance status 0 to 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
  • Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years
  • 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
  • Contraindication towards MRI imaging with contrast
  • Chronic kidney disease stage IV or V or end stage renal disease

Study Design

Enrollment

170 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Screening MRI

Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.

Interventions

Magnetic Resonance Imaging

Participants will undergo MRI imaging with and without contrast.

Primary outcome measure

  • Rate of Brain Metastasis [ Time Frame: at Baseline ]
  • Rate of Brain Metastasis [ Time Frame: up to 6 months ]

Central Contacts and Locations

Central contacts

Robin Dowell

813-745-0393Robin.Dowell@moffitt.org

Locations

Morton Plant Mease- Baycare

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Ronica H. Nanda, MD

Ronica.Nanda@baycare.org

Principal Investigator:

Ronica H. Nanda, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • Stage IV Breast Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.