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NCT01423123 · ClinicalTrials.gov registry record · Phase 1
Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer
A Phase 1 study, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01423123: Completed Phase 1 study, sponsored by NSABP Foundation.
NCT01423123 is a Phase 1 study that has completed, run by NSABP Foundation. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01423123, a Phase 1 study, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The FB-8 study is designed as an open label, single arm, Phase I dose-escalation study evaluating the combination of weekly paclitaxel with neratinib and trastuzumab in women with metastatic, HER2-positive breast cancer. The primary aim of this study is to determine the safety and tolerability of the three-drug combination.
Primary Outcome
Number of patients experiencing dose limiting toxicities (DLT).
Interventions
- DRUG Neratinib
- DRUG Paclitaxel
- BIOLOGICAL trastuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT01423123 record still lists
NCT01423123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Neratinib is the first listed.
NCT01423123 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01423123 about?
NCT01423123 is a clinical study titled "Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer". The FB-8 study is designed as an open label, single arm, Phase I dose-escalation study evaluating the combination of weekly paclitaxel with neratinib and trastuzumab in women with metastatic, HER2-positive breast cancer. The primary aim of this study is to determine the safety and tolerability of th...
What is the current status of trial NCT01423123?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2011-05. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01423123?
The interventions under investigation include: Neratinib (DRUG), Paclitaxel (DRUG), trastuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01423123?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01423123's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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