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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 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 139

Last updated 2026-08-11

No results posted yet for this study

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 Cancer
  • Breast Carcinoma
  • Cancer of the Breast
  • Malignant Neoplasm of Breast

Interventions

OTHER

Arm 1

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Takeo Fujii, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-16
Primary Completion
2033-07-01
Completion
2034-07-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619534 on ClinicalTrials.gov