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NCT01827787 · ClinicalTrials.gov registry record · Phase 2
Eribulin in HER2 Negative Metastatic BrCa
A Phase 2 study of Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
- 7
- Study locations
NCT01827787: Completed Phase 2 study of Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT01827787 is a Phase 2 study of Breast Cancer that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 83 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01827787, a Phase 2 study of Breast Cancer, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
- 7
- Study locations
Study Summary
Improvements in outcomes with metastatic breast cancer (MBC) have been observed in the last 30 years, however, overall prognosis remains poor with median survival of 2 to 3 years. Long term complete responses are observed only for a minority of MBC patients (2-5%) and MBC remains an incurable disease for most patients. Eribulin is a chemotherapy approved by the US FDA in November of 2010 to treat patients with MBC who have received at least two prior chemotherapy regimens. In this research study, the investigators are looking to see how well eribulin helps participants with MBC in an earlier-line setting. Eribulin works by interfering with cancer cell division, growth and spread.
Primary Outcome
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and a
Conditions Studied
Interventions
- DRUG Eribulin
Study Locations (7)
Massachusetts
- Dana-Farber Cancer Institute at Faulkner Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
- DF/BWCC at Milford Regional Cancer Center - Milford
- South Shore Hospital - Weymouth
Maine
- Eastern Maine Medical Center - Bangor
New Hampshire
- Dana-Farber/New Hampshire Oncology-Hematology - Londonderry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
What the finished NCT01827787 record still lists
NCT01827787 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Eribulin is the first listed.
NCT01827787 lists 7 locations in 3 states (Massachusetts, Maine, New Hampshire).
Frequently Asked Questions
What is clinical trial NCT01827787 about?
NCT01827787 is a clinical study titled "Eribulin in HER2 Negative Metastatic BrCa". Improvements in outcomes with metastatic breast cancer (MBC) have been observed in the last 30 years, however, overall prognosis remains poor with median survival of 2 to 3 years. Long term complete responses are observed only for a minority of MBC patients (2-5%) and MBC remains an incurable diseas...
What is the current status of trial NCT01827787?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2013-05. Estimated completion is 2016-05.
What conditions does trial NCT01827787 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01827787?
The interventions under investigation include: Eribulin (DRUG).
Who is sponsoring clinical trial NCT01827787?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01827787 being conducted?
This trial has 7 study locations across Maine, Massachusetts, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01827787's enrollment target sits among peer trials
83 637th of 1224 higher than 587 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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