Monitoring cancer spread to the brain in breast cancer patients
Feasibility of Multi-modality Central Nervous System Evaluation in HER2+ Breast Cancer Patients
NA · Memorial Sloan Kettering Cancer Center · NCT05130840
This study is testing if brain scans and spinal fluid tests can help find early signs of cancer spreading to the brain in patients with HER2-positive breast cancer who don't have brain disease yet.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05130840 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of brain scans and cerebrospinal fluid (CSF) testing in detecting early signs of central nervous system (CNS) metastases in patients with HER2-positive breast cancer. By identifying these metastases early, the researchers aim to initiate immediate treatment to prevent further progression of the disease. Participants will undergo MRI scans and lumbar punctures to collect CSF for analysis. The study focuses on patients with varying stages of HER2-positive breast cancer who do not currently exhibit CNS disease.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with Stage II-III or Stage IV HER2-positive breast cancer without CNS disease.
Not a fit: Patients who already have CNS metastases or cannot undergo MRI with gadolinium will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and treatment of CNS metastases, potentially improving outcomes for breast cancer patients.
How similar studies have performed: While similar approaches have been explored, this specific methodology of proactive monitoring in asymptomatic patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with Stage IV metastatic HER2+ breast cancer without CNS disease s/p 1 or more lines of HER2 directed therapy (Cohort A Only) * Patients with Stage II-III HER2+ breast cancer without CNS disease (Cohort B Only) * Male and Female participants Age ≥18 years * HER2+ as defined by ASCO/CAP guidelines\* * Ability to undergo bedside Lumbar puncture to obtain cerebrospinal fluid; if beside LP is not successful due to patient discomfort or inability to obtain spinal fluid then patients will be offered LP through interventional radiology and patients will continue to be monitored on study * Patients with breast implants and/or tissue expanders are eligible if they are able to safely undergo an MRI * Able to provide written informed consent \*ASCO/CAP guidelines: HER2+ defined as IHC 3+ positive and/or by ISH average copy number ≥ 6 signals/cell Exclusion Criteria: * Patients who are unable to undergo MRI with gadolinium * Patients with CNS Metastases on Screening MRI * Patients with Positive Cytology on Screening Bedside lumbar puncture
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Jessica Wilcox, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Jessica Wilcox, MD
- Email: wilcoxj@mskcc.org
- Phone: 212-639-6767
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: Breast Cancer, Central Nervous System, HER2+ Breast, 21-140