Recruiting

Sample Collection

Sponsor:

National Cancer Institute (NCI)

Code:

NCT07619534

Conditions

Breast Cancer

Breast Carcinoma

Cancer of the Breast

Malignant Neoplasm of Breast

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Arm 1

Study Details

Brief 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

Study ID

NCT07619534

Start date

Sep 16, 2026

Status verified date

Sep 9, 2026

Completion date

Jul 1, 2034

Anticipated

Primary completion date

Jul 1, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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 Design

Enrollment

139 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Cohort 2

Participants with metastatic HER2+ BC without a history or active radiographically detectable CNS disease who underwent at least one systemic therapy

Cohort 3

Participants with newly diagnosed mTNBC without a history or active radiographically detectable CNS disease and without prior systemic therapies

Cohort 4

Participants with newly diagnosed metastatic HER2+ BC without a history or active radiographically detectable CNS disease and without prior systemic therapies

Interventions

Arm 1

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

Primary outcome measure

  • Collection of CSF samples [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

National Cancer Institute Referral Office

888-624-1937ncimo_referrals@mail.nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 11, 2026

Last verified

Sep 9, 2026

Keywords

  • Triple Negative Breast Cancer (TNBC)
  • HER2-Postitive
  • Metastatic Breast Cancer
  • Cerebral Spinal Fluid Collection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-11.