Breast Cancer, Leptomeningeal Metastasis
Conditions
Keywords
Breast Carcinoma, Breast tumors, Cancer of the Breast, Malignant tumor of the breast, breast cancer, leptomeningeal metastasis
Brief summary
This study will prospectively enroll 36 evaluable subjects with breast cancer who are undergoing workup for clinical suspicion of leptomeningeal metastasis (LM). Neuroimaging consisting of MRI of the brain or total spine (or both, as clinically indicated) will be obtained in all patients. Patients will also undergo a lumbar puncture and standard CSF evaluation, which may consist of intracranial pressure measurement, CSF protein, glucose, white and red cell analysis, infectious cultures, as well as conventional cytopathologic analysis (cytocentrifuge). An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.
Detailed description
Leptomeningeal metastasis (LM) is a condition in which cancer cells seed the meninges and may go on to invade the brain parenchyma, spinal cord, cranial nerves or peripheral nerves. It is a devastating complication of breast cancer, and is often considered in the differential diagnosis when patients with breast cancer present with new neurologic symptoms. It was previously thought to be a rare occurrence, but autopsy series have shown the true overall incidence to be up to 8%. In fact, while the incidence of meningeal metastasis from other malignancies has decreased, the opposite is true of breast cancer, in which clinical evidence suggests an increasing incidence.
Interventions
DEVICEOncoCEE
The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA).
Sponsors
National Cancer Institute (NCI)
Biocept, Inc.
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (18 years or older) patients, with invasive breast cancer, of all racial and ethnic origins * Undergoing lumbar puncture for clinical or radiographic suspicion of leptomeningeal metastasis * Provide study-specific informed consent * Patients with unequivocal or suspicious MRI findings. * Of those with a definitive diagnosis of LM (i.e. positive CSF cytology), 10 evaluable patients will be accrued.
Exclusion criteria
* Prior CSF fluid which identified malignant cells after 10 evaluable patients with positive CSF are accrued.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status) | 6 months | Total number of participants with leptomeningeal metastasis detected (ER status) |
| Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status) | 6 months | Total number of participants with leptomeningeal metastasis detected (HER2 status) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OncoCEE Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.
OncoCEE: The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA). | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | OncoCEE |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status)
Total number of participants with leptomeningeal metastasis detected (ER status)
Time frame: 6 months
Population: Only includes patients with metastatic breast cancer enrolled with matched samples.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OncoCEE | Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status) | Detected by OncoCEE | 3 Participants |
| OncoCEE | Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status) | Detected by standard lumbar puncture | 1 Participants |
Primary
Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status)
Total number of participants with leptomeningeal metastasis detected (HER2 status)
Time frame: 6 months
Population: Only includes patients with metastatic breast cancer enrolled with matched samples.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OncoCEE | Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status) | Detected by OncoCEE | 0 Participants |
| OncoCEE | Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status) | Detected by standard lumbar puncture | 1 Participants |