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NCT01401959 · ClinicalTrials.gov registry record · Phase 2
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
A Phase 2 study of Metastatic Breast Cancer, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 127
- Enrollment target
- 18
- Study locations
NCT01401959: Completed Phase 2 study of Metastatic Breast Cancer, sponsored by SCRI Development Innovations.
NCT01401959 is a Phase 2 study of Metastatic Breast Cancer that has completed, run by SCRI Development Innovations. The registered enrollment target is 127 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (38% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01401959, a Phase 2 study of Metastatic Breast Cancer, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 127 participants
- Enrollment target
- 18
- Study locations
Study Summary
The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients who have residual invasive disease in breast or lymph node tissue following standard neoadjuvant chemotherapy and surgery regimen. Three cohorts of patients will be evaluated separately based on tumor type: triple-negative, hormone-receptor-positive/HER2-negative, and HER2-positive breast cancers.
Primary Outcome
The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Eribulin
Study Locations (18)
Florida
- Florida Cancer Specialists North - Fort Myers
- Florida Cancer Specialists South - Fort Myers
- Watson Clinic Center for Cancer Care and Research - Lakeland
- Florida Hospital Cancer Insitute - Orlando
Maryland
- Center for Cancer and Blood Disorders - Bethesda
- National Capital Clinical Research Consortium - Bethesda
New Jersey
- Atlantic Health System - Morristown
- Hematology Oncology Associates of Northern NJ - Morristown
Tennessee
- Chattanooga Oncology Hematology Associates - Chattanooga
- Tennessee Oncology - Nashville
Texas
- Texas Health Physician Group - Arlington
- The Center for Cancer and Blood Disorders - Fort Worth
Georgia
- Northeast Georgia Medical Center - Gainesville
Indiana
- Providence Medical Group - Terre Haute
Maine
- Mercy Hospital - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2011-09-23 |
| Est. Completion | 2017-04-03 |
| Phase | Phase 2 |
What the finished NCT01401959 record still lists
NCT01401959 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Trastuzumab is the first listed.
NCT01401959 lists 18 locations in 11 states (Florida, Maryland, New Jersey).
Frequently Asked Questions
What is clinical trial NCT01401959 about?
NCT01401959 is a clinical study titled "Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy". The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients who have residual invasive disease in breast or lymph node tissue following standard neoadjuvant chemotherapy and surgery regimen. Three cohorts of patients will be evaluated separately based on tumor type: ...
What is the current status of trial NCT01401959?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2011-09-23. Estimated completion is 2017-04-03.
What conditions does trial NCT01401959 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT01401959?
The interventions under investigation include: Trastuzumab (DRUG), Eribulin (DRUG).
Who is sponsoring clinical trial NCT01401959?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01401959 being conducted?
This trial has 18 study locations across Florida, Georgia, Indiana, Maine, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01401959's enrollment target sits among peer trials
127 48th of 139 higher than 92 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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.
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