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NCT01881230 · ClinicalTrials.gov registry record · Phase 2
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 191
- Enrollment target
NCT01881230: Completed Phase 2 study, sponsored by Celgene.
NCT01881230 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 191 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01881230, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 191 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.
Primary Outcome
PFS was defined as the time from the date of randomization to the date of disease progression or death from any cause on or prior to the data cutoff date for the statistical analysis, whichever occurred earlier. Tumor responses were assessed every 6 weeks using, Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and defined as: Complete response (CR) is the disappearance of all target lesions; Partial response (PR) occurs when at least a 30% decrease in the sum of diameters of target lesi
Interventions
- DRUG Carboplatin
- DRUG Gemcitabine
- DRUG nab-Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2013-09-26 |
| Est. Completion | 2016-10-28 |
| Phase | Phase 2 |
What the finished NCT01881230 record still lists
NCT01881230 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT01881230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01881230 about?
NCT01881230 is a clinical study titled "Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)". The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic tri...
What is the current status of trial NCT01881230?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 191 participants. The study started on 2013-09-26. Estimated completion is 2016-10-28.
What interventions are being tested in trial NCT01881230?
The interventions under investigation include: Carboplatin (DRUG), Gemcitabine (DRUG), nab-Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT01881230?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01881230's enrollment target sits among peer trials
191 353rd of 2000 higher than 1,648 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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