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NCT01033032 · ClinicalTrials.gov registry record · Phase 1
Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer
A Phase 1 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
NCT01033032: Completed Phase 1 study, sponsored by SCRI Development Innovations.
NCT01033032 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01033032, a Phase 1 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
Study Summary
Doxorubicin has been an integral part of the treatment of women with breast cancer for many years. Since amrubicin may have more activity than doxorubicin, as well as less cardiotoxicity, evaluation of amrubicin in the treatment of advanced breast cancer should be a priority. In this Phase II study, the investigators propose an evaluation of single-agent amrubicin as second- or third-line treatment for women with metastatic breast cancer.
Primary Outcome
Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on the study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase
Interventions
- DRUG Amrubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2009-12 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT01033032 record still lists
NCT01033032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 1 intervention - of which Amrubicin is the first listed.
NCT01033032 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01033032 about?
NCT01033032 is a clinical study titled "Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer". Doxorubicin has been an integral part of the treatment of women with breast cancer for many years. Since amrubicin may have more activity than doxorubicin, as well as less cardiotoxicity, evaluation of amrubicin in the treatment of advanced breast cancer should be a priority. In this Phase II study,...
What is the current status of trial NCT01033032?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2009-12. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01033032?
The interventions under investigation include: Amrubicin (DRUG).
Who is sponsoring clinical trial NCT01033032?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01033032's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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