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NCT01086605 · ClinicalTrials.gov registry record · Phase 2
Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer
A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT01086605: Completed Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT01086605 is a Phase 2 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01086605, a Phase 2 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well pixantrone dimaleate works in treating patients with HER2-negative metastatic breast cancer.
Primary Outcome
The proportion of confirmed responses will be estimated by the number of women who achieve a CR or PR on two consecutive evaluations at least 6-8 weeks apart depending on the dose level. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients at each dose level. Confidence intervals for the true success proportion at each dose level will be calculated according to the approach of Duffy and Santner. Response will be evaluated in t
Interventions
- DRUG pixantrone dimaleate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-11-15 |
| Phase | Phase 2 |
What the finished NCT01086605 record still lists
NCT01086605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which pixantrone dimaleate is the first listed.
NCT01086605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01086605 about?
NCT01086605 is a clinical study titled "Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells. PURPOSE: This randomized phase II tr...
What is the current status of trial NCT01086605?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2010-05. Estimated completion is 2014-11-15.
What interventions are being tested in trial NCT01086605?
The interventions under investigation include: pixantrone dimaleate (DRUG).
Who is sponsoring clinical trial NCT01086605?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01086605's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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