Breast CancerNCT07619534
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
An observational study of Breast Cancer and Breast Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer, Breast Carcinoma, Cancer of the Breast
- What is being tested?
- Arm 1
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 1 Jul 2034
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
- OR
- --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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937, ncimo_referrals@mail.nih.gov
About this study
Official title: Sample Collection Study to Analyze Cerebral Spinal Fluid as a Biomarker for Brain Metastasis in Metastatic Breast Cancer
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.
Read more
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.
Read the detailed description
Background
- Breast cancer (BC) is the most common cancer among women and the second leading cause of cancer-related deaths in women.
- Among the four common metastatic sites of BC - liver, lung, bone, and brain - brain metastases result in the most severe adverse effects and poorest survival outcomes.
- Despite robust preclinical data on potential drugs for brain metastasis prevention, designing prevention trials remains challenging due to the difficulty of identifying high-risk populations, the long time required for outcomes to develop, and the associated costs.
- Circulating-tumor DNA (ctDNA) from cerebrospinal fluid (CSF) collected from patients who had been locally treated for brain metastases and showed no evidence of metastases on MRI displayed a distinct mutation profile compared to plasma collected at the same time.
Primary Objective
-To collect 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
Eligibility
- Confirmed metastatic HER2+ BC or TNBC
- Age >=18 years
Design
- This pilot, single-site tissue collection trial aims to collect CSF samples for analysis as potential predictors of brain metastases.
- CSF, blood, tumor tissue, and saliva or buccal mucosa will be collected at baseline and optionally during the study.
- All participants will be followed up for brain metastasis development every 6 months for up to 3 years.
- Being tested
- Arm 1
- Keywords
- Triple Negative Breast Cancer (TNBC), HER2-Postitive, Metastatic Breast Cancer, Cerebral Spinal Fluid Collection
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1Other
Collection of CSF, blood, tumor tissue, and saliva or buccal mucosa
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Arm 1 | |
| Cohort 3 | Participants with newly diagnosed mTNBC without a history or active radiographically detectable CNS disease and without prior systemic therapies Receives: 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 Receives: Other: Arm 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start28 Oct 2026 (estimated)
- Primary completion1 Jul 2033 (estimated)
- Study completion1 Jul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Takeo Fujii, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619534
- Sponsor's protocol ID
- 10002493
- Other IDs
- 002493-C
- Status last verified
- 9 Sep 2026
- First submitted
- 30 May 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.