Screening brain MRIs for patients with stage IV breast cancer
Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute · NCT05115474
This study tests if regular brain MRI scans can help find hidden issues in the brains of patients with stage IV breast cancer who don’t have any symptoms yet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute (other) |
| Locations | 2 sites (Clearwater, Florida and 1 other locations) |
| Trial ID | NCT05115474 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of screening brain MRIs in neurologically asymptomatic patients diagnosed with stage IV breast cancer. It focuses on patients with various subtypes of breast cancer, including triple-negative, HER2-positive, and hormone receptor-positive types. The study aims to determine if routine MRI screenings can provide valuable insights into the progression of the disease in these patients. Participants will undergo MRI scans to assess any potential brain metastases that may not yet present symptoms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage IV breast cancer who are neurologically asymptomatic and have progressed past first-line therapy.
Not a fit: Patients with a prior diagnosis of brain metastases or those exhibiting neurological symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of brain metastases in breast cancer patients, potentially improving treatment outcomes.
How similar studies have performed: While the approach of screening MRIs in asymptomatic patients is not widely tested, similar studies in other cancer types have shown promise in early detection.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clearwater, Florida and 1 other locations
- Morton Plant Mease- Baycare — Clearwater, Florida, United States (RECRUITING)
- Moffitt Cancer Center — Tampa, Florida, United States (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Kamran A Ahmed, MD — Moffitt Cancer Center
- Study coordinator: Robin Dowell
- Email: Robin.Dowell@moffitt.org
- Phone: 813-745-0393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Triple Negative Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer, Stage IV Breast Cancer