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NCT01091454 · ClinicalTrials.gov registry record · Phase 2
Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT01091454: Completed Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT01091454 is a Phase 2 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01091454, a Phase 2 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
This phase II trial studies how well brostallicin and cisplatin work in treating patients with breast cancer that has spread to other parts of the body (metastatic) and does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from spreading.
Primary Outcome
A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at
Interventions
- DRUG cisplatin
- DRUG brostallicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-11-01 |
| Phase | Phase 2 |
What the finished NCT01091454 record still lists
NCT01091454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which cisplatin is the first listed.
NCT01091454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01091454 about?
NCT01091454 is a clinical study titled "Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer". This phase II trial studies how well brostallicin and cisplatin work in treating patients with breast cancer that has spread to other parts of the body (metastatic) and does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2) on it...
What is the current status of trial NCT01091454?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2010-06. Estimated completion is 2014-11-01.
What interventions are being tested in trial NCT01091454?
The interventions under investigation include: cisplatin (DRUG), brostallicin (DRUG).
Who is sponsoring clinical trial NCT01091454?
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 NCT01091454's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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