Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases

NCT07619534 | Not Yet Recruiting

• 2 other identifiers: 10002493002493-C
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Breast cancer is the most common cancer among women. It can often spread to the liver, lungs, bones, or brain. Breast cancer that spreads to the brain is often fatal. Researchers want to know if tumor DNA found in spinal fluid, blood, or tumor tissue can help predict when the cancer will spread to the brain. They want to collect these fluid and tissue samples for research. Objective: To collect spinal fluid and other samples from people with breast cancer that has spread to other parts of the body. Eligibility: People aged 18 years and older with HER2-positive or triple negative breast cancer. The cancer must have spread to other parts of the body but not to the brain. Design: Participants will be screened. They will have blood tests to assess kidney function. They will have an imaging scan of the brain. Participants will come to the NIH clinic to have their samples collected:

• Spinal fluid. A thin needle will be inserted into the lower back to draw out a sample of fluid from the space around the spinal cord. A physical exam and blood tests will be done to make sure it is safe for participants to have this procedure.
• Blood.
• Saliva or cheek swabs. They will rub a cotton swab inside of their mouth.
• Tumor samples. If participants have had samples of tumor tissue (biopsies) collected in the past, leftover tissue may be used for this study. Participants will be contacted for follow-up every 6 months for 3 years. They may return once a year to provide further samples....

Conditions

Breast Carcinoma; Cancer of the Breast; Malignant Neoplasm of Breast; Breast Cancer

Keywords

Triple Negative Breast Cancer (TNBC); HER2-Postitive; Metastatic Breast Cancer; Cerebral Spinal Fluid Collection

Outcome Measures

Primary Outcomes (1)

• Collection of CSF samples

  CSF samples from participants with metastatic triple negative breast cancer (TNBC) and HER2+ breast cancer (BC) with no prior history nor active radiographically detectable brain metastases will be collected to perform downstream analyses will be collected and summarized/described descriptively.

  Up to 3 years

Study Arms (4)

Cohort 1

Participants with metastatic triple negative breast cancer (mTNBC) without a history or active radiographically detectable CNS disease who underwent at least one systemic therapy

Other: Arm 1

Cohort 2

Participants with metastatic HER2+ BC without a history or active radiographically detectable CNS disease who underwent at least one systemic therapy

Other: Arm 1

Cohort 3

Participants with newly diagnosed mTNBC without a history or active radiographically detectable CNS disease and without prior systemic therapies

Other: Arm 1

Cohort 4

Participants with newly diagnosed metastatic HER2+ BC without a history or active radiographically detectable CNS disease and without prior systemic therapies

Other: Arm 1

Interventions

Arm 1 OTHER

Collection of CSF, blood, tumor tissue, and saliva or buccal mucosa

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with metastatic triple negative breast cancer (TNBC) and HER2-positive breast cancer with no prior history nor active radiographically detectable brain metastases.

You may qualify if:

• Pathology documentation of histologically confirmed HER2+ BC or TNBC with a history of metastatic disease.
• Participants must be able to undergo lumbar puncture (LP) and brain MRI.
• Women age \>= 18 years
• Adequate organ function as defined below:
• Creatinine \<=1.5 x institutional upper limit of normal (ULN)
• Calculated Creatinine clearance \>=40 mL/min/1.73 m2 for individuals with creatinine levels above institutional ULN (using either Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation)
• \- Participants must be able to understand and willing to sign a written informed consent document.

You may not qualify if:

• Prior history or current MRI-detected brain metastasis or leptomeningeal disease
• Previous history of any invasive malignancies, except for surgically resected local cutaneous malignancies.
• Pregnancy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Takeo Fujii, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann C McCoy, R.N.

CONTACT

(240) 760-6021; ann.mccoy@nih.gov

Takeo Fujii, M.D.

CONTACT

(240) 858-3558; takeo.fujii@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2033
• Study Completion (Estimated): July 1, 2034
• Last Updated: June 5, 2026

Record last verified: 2026-06-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available as soon as possible or at the time of associated publication. Data not published in a manuscript will be shared via public source once the data set completes QC.
• Access Criteria: Clinical data will be made available upon request and with the permission of the study PI. Genomic data are made available via dbGAP through requests to the data custodians.

Locations

US (1)