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NCT00331552 · ClinicalTrials.gov registry record · Phase 1
Doxorubicin Hydrochloride Liposome, Cyclophosphamide, and Trastuzumab in Treating Patients With Stage IV Breast Cancer
A Phase 1 study of HER2-positive Breast Cancer and Stage IV Breast Cancer, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00331552: Completed Phase 1 study of HER2-positive Breast Cancer and Stage IV Breast Cancer, sponsored by University of Washington.
NCT00331552 is a Phase 1 study of HER2-positive Breast Cancer and Stage IV Breast Cancer that has completed, run by University of Washington. The registered enrollment target is 30 participants, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00331552, a Phase 1 study of HER2-positive Breast Cancer and Stage IV Breast Cancer, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with trastuzumab may be a better way to block tumor growth.
Primary Outcome
The dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment
Conditions Studied
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL trastuzumab
- DRUG pegylated liposomal doxorubicin hydrochloride
Study Locations (1)
Washington
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-02 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT00331552 record still lists
NCT00331552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which cyclophosphamide is the first listed.
NCT00331552 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT00331552 about?
NCT00331552 is a clinical study titled "Doxorubicin Hydrochloride Liposome, Cyclophosphamide, and Trastuzumab in Treating Patients With Stage IV Breast Cancer". Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. ...
What is the current status of trial NCT00331552?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2006-02. Estimated completion is 2012-02.
What conditions does trial NCT00331552 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer, Stage IV Breast Cancer, Recurrent Breast Cancer, Male Breast Cancer.
What interventions are being tested in trial NCT00331552?
The interventions under investigation include: cyclophosphamide (DRUG), trastuzumab (BIOLOGICAL), pegylated liposomal doxorubicin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00331552?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00331552 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 HER2-positive 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 NCT00331552's enrollment target sits among peer trials
30 41st of 58 higher than 16 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive 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.
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