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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Creatinine <=1.5 x institutional upper limit of normal (ULN)

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Arm 1

    Other intervention

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

Treatment groups

139 Participants
are divided into 4 treatment groups
Group A: Cohort 11 intervention
Group B: Cohort 21 intervention
Group C: Cohort 31 intervention
Group D: Cohort 41 intervention

Trial outcomes

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.

Time frame
Up to 3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: