Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02571530 · ClinicalTrials.gov registry record · Phase 1
Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer
A Phase 1 study, sponsored by Northwell Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02571530 is a Phase 1 study that was terminated before completion, run by Northwell Health. The registered enrollment target is 2 participants.
The verdict
NCT02571530, a Phase 1 study, was terminated before completion, sponsored by Northwell Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of administering a single dose of trastuzumab into the artery for the treatment of brain metastasis(es) from HER2/neu positive breast cancer. This study will try to determine the best tolerated single dosage of trastuzumab administered into arteries by gradually increasing the dosage given to participants as the study progresses. Early participants will receive a dosage of 1 mg/kg. As more participants enroll into the study, this single dosage will be increased at designated levels up to 8 mg/kg, if it's determined to be safe to increase. Trastuzumab is a type of antibody, which is a protein used by the body's immune system to fight against pathogens such as bacteria and viruses. This antibody binds to cell receptors known as the HER2/neu tyrosine kinase receptor. These receptors are expressed in certain cancer subtypes such as breast cancer. By blocking signaling through this HER2/neu receptor, trastuzumab can slow down or stop the over-expression of the HER2/neu protein. Over-expression of HER2/neu has been shown to play a role in the development and progression of certain types of breast cancer. Therefore, by slowing down or stopping the expression of HER2/neu, investigators hope to slow down or stop the growth of metastasis(es) and increase the responsiveness to therapy.
Interventions
- DRUG Intra-arterial Cerebral Infusion of Trastuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-08 |
| Est. Completion | 2021-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02571530
The ClinicalTrials.gov registry entry for NCT02571530 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intra-arterial Cerebral Infusion of Trastuzumab is the first listed.
NCT02571530 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02571530 about?
NCT02571530 is a clinical study titled "Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer". The purpose of this study is to evaluate the safety of administering a single dose of trastuzumab into the artery for the treatment of brain metastasis(es) from HER2/neu positive breast cancer. This study will try to determine the best tolerated single dosage of trastuzumab administered into arteri...
What is the current status of trial NCT02571530?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2015-08. Estimated completion is 2021-06.
What interventions are being tested in trial NCT02571530?
The interventions under investigation include: Intra-arterial Cerebral Infusion of Trastuzumab (DRUG).
Who is sponsoring clinical trial NCT02571530?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.