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NCT01445054 · ClinicalTrials.gov registry record · Early Phase 1
111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer
A Early Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 13
- Enrollment target
NCT01445054: Clinical Trial Early Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01445054 is a Early Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445054, a Early Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
Background: * Some breast cancer cells have specific proteins (receptors) on their surface that make the tumor grow faster than normal cells. One of these receptors is called HER2/neu. * An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the cancer cell. * Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has been attached to a tiny amount of Herceptin. Objectives: -To see if Indium-Herceptin provides information about the characteristics of the breast cancer in women whose tumors express HER2/neu and those whose tumors do not. Eligibility: -Women 18 years or older with primary or metastatic breast cancer who have not received treatment with herceptin for at least 6 months before enrollment into the study. Design: * Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu status. * Patients have a physical examination and review of medical records. * Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma camera that detects the radioactivity in the Indium-Herceptin. * Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine the best time to image after injection of Indium-Herceptin. * Blood samples are obtained every day of scanning to monitor the effects, if any, of the Indium-Herceptin and to see how fast the agent leaves the body.
Interventions
- DRUG 111Indium CHX-A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2007-03-01 |
| Est. Completion | 2014-08-20 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01445054
The ClinicalTrials.gov registry entry for NCT01445054 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 111Indium CHX-A is the first listed.
NCT01445054 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01445054 about?
NCT01445054 is a clinical study titled "111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer". Background: * Some breast cancer cells have specific proteins (receptors) on their surface that make the tumor grow faster than normal cells. One of these receptors is called HER2/neu. * An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the cancer cell. * Indium-Hercept...
What is the current status of trial NCT01445054?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 13 participants. The study started on 2007-03-01. Estimated completion is 2014-08-20.
What interventions are being tested in trial NCT01445054?
The interventions under investigation include: 111Indium CHX-A (DRUG).
Who is sponsoring clinical trial NCT01445054?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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