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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: Clinical Trial Phase 1 study, sponsored by Northwell Health.
NCT02571530 is a Phase 1 study that was terminated before completion, run by Northwell Health. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Maximum tolerated dose (MTD) the highest dose at which there are no dose limiting toxicities.
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 |
Why NCT02571530 stopped before completion
NCT02571530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Intra-arterial Cerebral Infusion of Trastuzumab is the first listed.
NCT02571530 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02571530's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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