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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

Sample Collection Study to Analyze Cerebral Spinal Fluid as a Biomarker for Brain Metastasis in Metastatic Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years
  • Procedures mentioned: Blood draws, Physical exams, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "They will have blood tests to assess kidney function."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects spinal fluid, blood, and other samples to learn if tumor DNA can help predict when breast cancer will spread to the brain. It is for women age 18 or older with HER2-positive or triple-negative breast cancer that has spread to other parts of the body, but not to the brain.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Lab records must confirm HER2-positive or triple-negative breast cancer that has spread to other parts of the body.
  • Able to have a spinal tap, which uses a needle in the lower back to collect fluid around the spinal cord.
  • Able to have a brain MRI scan.
  • Kidney test results must meet the study’s safety limits.
  • Able to understand the study and willing to sign a consent form.

Who can't join

  • Cancer that has spread to the brain or its surrounding tissue and fluid, either in the past or seen on a current MRI.
  • A past invasive cancer, meaning cancer that grew into nearby tissue. Local skin cancers removed by surgery are allowed.
  • Pregnancy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION CRITERIA: * 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. EXCLUSION CRITERIA: * 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

Study sites (1)

MD