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
Breast Cancer · Breast Carcinoma · Cancer of the Breast · Malignant Neoplasm of Breast
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - 120 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 139 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
- 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
Población del estudio
Participants with metastatic triple negative breast cancer (TNBC) and HER2-positive breast cancer with no prior history nor active radiographically detectable brain metastases.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
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
Arm 1 OTHER
Collection of CSF, blood, tumor tissue, and saliva or buccal mucosa
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Collection of CSF samples
Plazo: Up to 3 years
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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
National Institutes of Health Clinical CenterBethesda, Maryland, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- National Cancer Institute (NCI)
- Inicio del estudio
- 15 nov 2026 Estimado
- Finalización primaria
- 1 jul 2033 Estimado
- Finalización del estudio
- 1 jul 2034 Estimado
- Primera publicación
- 2 jun 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Sample Collection Study to Analyze Cerebral Spinal Fluid as a Biomarker for Brain Metastasis in Metastatic Breast Cancer
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026