Clinical trial NCT05130840: Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer
Official title: Feasibility of Multi-modality Central Nervous System Evaluation in HER2+ Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Central Nervous System
HER2+ Breast
21-140
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This represents a two-cohort feasibility study to establish the feasibility of a multi-modality central nervous system (CNS) disease detection platform in patients with HER2+ breast cancer with no known CNS metastatic disease. Patients will enroll into one of 2 cohorts. Cohort A will be open to patients with Stage IV HER2+ breast cancer and Cohort B will include patients with Stage II-III HER2+ breast cancer.
Primary purpose: DIAGNOSTIC

Brief summary: The researchers doing this study think that performing scans of the brain and testing cerebrospinal fluid (CSF) in people with HER2-positive breast cancer may be an effective way of identifying the early onset of CNS metastases (such as brain cancer). If the researchers can identify the early onset of CNS metastases, they can immediately treat that cancer and possibly prevent it from worsening. Currently, people with breast cancer don't usually have scans of the brain or CSF testing unless they are experiencing symptoms of CNS metastases.


Eligibility 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

Primary outcomes:
measure: Number of eligible patients completing initial MRI
timeFrame: 2 years
measure: Percentage of eligible patients completing cerebrospinal fluid (CSF) evaluation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jessica Wilcox, MD
role: PRINCIPAL_INVESTIGATOR
References: