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NCT00193037 · ClinicalTrials.gov registry record · Phase 2
Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT00193037: Completed Phase 2 study of Breast Cancer, sponsored by SCRI Development Innovations.
NCT00193037 is a Phase 2 study of Breast Cancer that has completed, run by SCRI Development Innovations. The registered enrollment target is 102 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00193037, a Phase 2 study of Breast Cancer, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study Summary
The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.
Primary Outcome
ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Liposomal Doxorubicin
Study Locations (1)
Tennessee
- Tennessee Oncology - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2001-02 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00193037 record still lists
NCT00193037 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Docetaxel is the first listed.
NCT00193037 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT00193037 about?
NCT00193037 is a clinical study titled "Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer". The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any po...
What is the current status of trial NCT00193037?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2001-02. Estimated completion is 2009-11.
What conditions does trial NCT00193037 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00193037?
The interventions under investigation include: Docetaxel (DRUG), Liposomal Doxorubicin (DRUG).
Who is sponsoring clinical trial NCT00193037?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00193037 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT00193037's enrollment target sits among peer trials
102 557th of 1224 higher than 664 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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