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NCT00425672 · ClinicalTrials.gov registry record · Phase 1
ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment
A Phase 1 study of Stage IV Breast Cancer and Stage IIIA Breast Cancer, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00425672: Completed Phase 1 study of Stage IV Breast Cancer and Stage IIIA Breast Cancer, sponsored by University of Washington.
NCT00425672 is a Phase 1 study of Stage IV Breast Cancer and Stage IIIA Breast Cancer that has completed, run by University of Washington. The registered enrollment target is 15 participants, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00425672, a Phase 1 study of Stage IV Breast Cancer and Stage IIIA Breast Cancer, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: ONTAK may be able to help reduce the type of cells that prevent other types of immune cells from attacking the breast cancer cells. PURPOSE: This phase I/II trial is studying the safety of ONTAK and its possible side effects to see how well it works in treating patients with advanced breast cancer that did not respond to previous treatment.
Primary Outcome
Subjects are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, serum albumin, complete blood counts, symptom assessment, and physical exams performed at every cycle until 3 weeks after the final dose of ONTAK. All adverse events for all systems are graded on a scale of 1-5 using CTCAE v3.0.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- OTHER immunohistochemistry staining method
- OTHER flow cytometry
- OTHER enzyme-linked immunosorbent assay
- BIOLOGICAL ONTAK
Study Locations (1)
Washington
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2005-09 |
| Phase | Phase 1 |
What the finished NCT00425672 record still lists
NCT00425672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (77% lower).
The record links to 6 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00425672 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT00425672 about?
NCT00425672 is a clinical study titled "ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment". RATIONALE: ONTAK may be able to help reduce the type of cells that prevent other types of immune cells from attacking the breast cancer cells. PURPOSE: This phase I/II trial is studying the safety of ONTAK and its possible side effects to see how well it works in treating patients with advanced bre...
What is the current status of trial NCT00425672?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2005-09.
What conditions does trial NCT00425672 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Recurrent Breast Cancer.
What interventions are being tested in trial NCT00425672?
The interventions under investigation include: laboratory biomarker analysis (OTHER), immunohistochemistry staining method (OTHER), flow cytometry (OTHER), enzyme-linked immunosorbent assay (OTHER), ONTAK (BIOLOGICAL).
Who is sponsoring clinical trial NCT00425672?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00425672 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00425672's enrollment target sits among peer trials
15 28th of 30 higher than 3 of 30 other Stage IV Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Breast Cancer 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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