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NCT01268150 · ClinicalTrials.gov registry record · Phase 2
A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT01268150: Completed Phase 2 study, sponsored by Eisai.
NCT01268150 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01268150, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic breast cancer.
Primary Outcome
The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diam
Interventions
- DRUG Eribulin mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT01268150 record still lists
NCT01268150 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Eribulin mesylate is the first listed.
NCT01268150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01268150 about?
NCT01268150 is a clinical study titled "A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer". The purpose of this study is to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic breast cancer.
What is the current status of trial NCT01268150?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2011-02. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01268150?
The interventions under investigation include: Eribulin mesylate (DRUG).
Who is sponsoring clinical trial NCT01268150?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01268150's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 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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