search
Back to results

Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Lumbar puncture
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Central Nervous System, HER2+ Breast, 21-140

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Stage IV metastatic HER2+ breast cancer without CNS disease s/p 1 or more lines of HER2 directed therapy
  • Patients with Stage II-III HER2+ breast cancer without CNS disease
  • 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

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stage IV HER2+ breast cancer

Stage II-III HER2+ breast cancer

Arm Description

Once enrolled on study, patients will undergo screening MRI Brain (unless already done as standard of care within 2 months on enrollment to evaluate for CNS disease) as well as lumbar puncture to evaluate for CNS disease. Once on study, patients will undergo LP and MRI Brain at 2 timepoints 6 months apart (+/- 8 weeks). LP will be performed to analyze cerebrospinal fluid for: cytology, circulating tumor cells and cell-free DNA. 6-month intervals for investigations have been based on feedback from patient advocates as well as clinical determination.

Once enrolled on study, patients will undergo screening MRI Brain (unless already done as standard of care within 2 months on enrollment to evaluate for CNS disease) as well as lumbar puncture to evaluate for CNS disease. Once on study, patients will undergo LP and MRI Brain at 2 timepoints 6 months apart (+/- 8 weeks). LP will be performed to analyze cerebrospinal fluid for: cytology, circulating tumor cells and cell-free DNA. 6-month intervals for investigations have been based on feedback from patient advocates as well as clinical determination.

Outcomes

Primary Outcome Measures

Number of eligible patients completing initial MRI
will require 8 out of 10 eligible patients to successfully complete the initial MRI
Percentage of eligible patients completing cerebrospinal fluid (CSF) evaluation
will require 8 out of 10 eligible patients to successfully complete the CSF evaluation

Secondary Outcome Measures

Full Information

First Posted
November 22, 2021
Last Updated
July 18, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05130840
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Central Nervous System, HER2+ Breast, 21-140

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage IV HER2+ breast cancer
Arm Type
Experimental
Arm Description
Once enrolled on study, patients will undergo screening MRI Brain (unless already done as standard of care within 2 months on enrollment to evaluate for CNS disease) as well as lumbar puncture to evaluate for CNS disease. Once on study, patients will undergo LP and MRI Brain at 2 timepoints 6 months apart (+/- 8 weeks). LP will be performed to analyze cerebrospinal fluid for: cytology, circulating tumor cells and cell-free DNA. 6-month intervals for investigations have been based on feedback from patient advocates as well as clinical determination.
Arm Title
Stage II-III HER2+ breast cancer
Arm Type
Experimental
Arm Description
Once enrolled on study, patients will undergo screening MRI Brain (unless already done as standard of care within 2 months on enrollment to evaluate for CNS disease) as well as lumbar puncture to evaluate for CNS disease. Once on study, patients will undergo LP and MRI Brain at 2 timepoints 6 months apart (+/- 8 weeks). LP will be performed to analyze cerebrospinal fluid for: cytology, circulating tumor cells and cell-free DNA. 6-month intervals for investigations have been based on feedback from patient advocates as well as clinical determination.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
MRI Brain (unless already done as standard of care within 2 months on enrollment to evaluate for CNS disease) MRI Brain at 2 timepoints 6 months apart (+/- 8 weeks).
Intervention Type
Diagnostic Test
Intervention Name(s)
Lumbar puncture
Intervention Description
LP at 2 timepoints 6 months apart (+/- 8 weeks). LP will be performed to analyze cerebrospinal fluid for: cytology, circulating tumor cells and cell-free DNA.
Primary Outcome Measure Information:
Title
Number of eligible patients completing initial MRI
Description
will require 8 out of 10 eligible patients to successfully complete the initial MRI
Time Frame
2 years
Title
Percentage of eligible patients completing cerebrospinal fluid (CSF) evaluation
Description
will require 8 out of 10 eligible patients to successfully complete the CSF evaluation
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Patients with Stage II-III HER2+ breast cancer without CNS disease 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Wilcox, MD
Phone
212-639-6767
Email
wilcoxj@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Chau Dang, MD
Phone
914-367-7181
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Wilcox, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Wilcox, MD
Phone
212-639-6767
First Name & Middle Initial & Last Name & Degree
Chau Dang, MD
Phone
914-367-7181

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer

We'll reach out to this number within 24 hrs