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| Name | Class |
|---|---|
| Florida Breast Cancer Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening MRI | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Diagnostic Test | Participants will undergo MRI imaging with and without contrast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Brain Metastasis | Rate of brain metastasis by breast cancer subtype at baseline using MRI images. | at Baseline |
| Rate of Brain Metastasis | Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Asymptomatic Leptomeningeal Disease | Rate of asymptomatic leptomeningeal disease by breast cancer subtype at baseline and at 6 months or first systemic progression, using MRI images. | Baseline and at up to 6 months |
| Number of Brain Metastases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robin Dowell | Contact | 813-745-0393 | Robin.Dowell@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Kamran A Ahmed, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morton Plant Mease- Baycare | Recruiting | Clearwater | Florida | 33756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39851040 | Derived | Ahmed KA, Kim Y, Armaghani AJ, Arrington JA, Costa RL, Czerniecki BJ, Diaz R, Dowell RA, Extermann M, Forsyth PA, Lee KT, Loftus L, Mills MN, Phuoc VH, Rosa M, Soliman HH, Sam CS, Washington IR, Soyano AE, Han HS. Phase II trial of brain MRI surveillance in stage IV breast cancer. Neuro Oncol. 2025 Jul 30;27(6):1550-1558. doi: 10.1093/neuonc/noaf018. |
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Number of Brain Metastases at Diagnosis by Breast Cancer Subtype, using MRI images.
| Baseline |
| Overall Survival | Overall Survival (OS) will be measured from the initial on study date to the recorded date of death. | Up to 6 months |
| Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation | Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation by breast cancer type. | Up to 6 months |
| Brain Metastasis Specific Survival | Brain metastasis specific survival following brain metastasis by breast cancer subtype | Up to 6 months |
| Moffitt Cancer Center | Active, not recruiting | Tampa | Florida | 33612 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |