Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: Arm 1 for Breast Cancer

Background: Breast cancer is the most common cancer among women. It can often spread to the liver, lungs, bones, or brain.

Official registry: https://clinicaltrials.gov/study/NCT07619534 · National Cancer Institute (NCI) · enrollment listed as 139

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 139 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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

Interventions: Arm 1

Primary outcome (registry wording): Collection of CSF samples

Who it is for (from inclusion criteria)

  • Ages 18 Years to 120 Years
  • 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)
  • 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)

Public study contact (from the registry)

Ann C McCoy, R.N.

(240) 760-6021

ann.mccoy@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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Phase 2: testing Pembrolizumab (Keytruda) for Metastatic Colorectal Cancer

Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.

NCT01174121 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT07619534 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07619534?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07619534?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary