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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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower). 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.
Primary Outcome
Correlation between uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) and status of the tumor as determined by IHC
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 |
Why NCT01445054 stopped before completion
NCT01445054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which 111Indium CHX-A is the first listed.
NCT01445054 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01445054's enrollment target sits among peer trials
13 1503rd of 2000 higher than 472 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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