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NCT01439282 · ClinicalTrials.gov registry record · Phase 2
Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer
A Phase 2 study of Breast Cancer and Estrogen Receptor Positive Tumor, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
- 20
- Study locations
NCT01439282: Completed Phase 2 study of Breast Cancer and Estrogen Receptor Positive Tumor, sponsored by Eisai.
NCT01439282 is a Phase 2 study of Breast Cancer and Estrogen Receptor Positive Tumor that has completed, run by Eisai. The registered enrollment target is 77 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01439282, a Phase 2 study of Breast Cancer and Estrogen Receptor Positive Tumor, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65 subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal, estrogen receptor (ER)-positive breast cancer.
Primary Outcome
Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant's body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on
Conditions Studied
Interventions
- DRUG capecitabine
- DRUG eribulin mesylate
Study Locations (20)
Texas
- Texas Oncology-Austin Central - Austin
- Texas Oncology-Medical City Dallas - Dallas
- Texas Oncology-Dallas Presbyterian Hospital - Dallas
- Texas Oncology-Methodist Charlton Cancer Center - Dallas
- Texas Oncology-Baylor Charles A. Sammons Cancer Center - Dallas
- Texas Oncology- Denton South - Denton
- Texas Oncology-Fort Worth 12th Ave. - Fort Worth
- Texas Oncology-Memorial City - Houston
- Texas Oncology-Lewisville - Lewisville
- Texas Oncology-Paris - Paris
- Cancer Care Centers of South Texas - San Antonio
- Texas Oncology-Tyler - Tyler
Arizona
- Arizona Oncology Associates, PC - HOPE - Tucson
- Arizona Oncology Associates, PC - CASA - Tucson
New York
- New York Oncology Hematology, P.C. - Albany
- Sciode Medical Associates, PLLC, d.b.a. Eastchester Center - The Bronx
Florida
- Cancer Centers of Florida - Orlando
Georgia
- Northwest Georgia Oncology Centers, P.C. - Marietta
South Carolina
- Cancer Centers of the Carolinas - Greenville
Virginia
- Virginia Oncology Associates - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT01439282 record still lists
NCT01439282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 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 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which capecitabine is the first listed.
NCT01439282 names 20 study sites across 7 states, led by Texas, Arizona, New York.
Frequently Asked Questions
What is clinical trial NCT01439282 about?
NCT01439282 is a clinical study titled "Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer". This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65 subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal, estrogen receptor (ER)-positive breast...
What is the current status of trial NCT01439282?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2011-08. Estimated completion is 2014-05.
What conditions does trial NCT01439282 study?
This clinical trial studies the following conditions: Breast Cancer, Estrogen Receptor Positive Tumor.
What interventions are being tested in trial NCT01439282?
The interventions under investigation include: capecitabine (DRUG), eribulin mesylate (DRUG).
Who is sponsoring clinical trial NCT01439282?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01439282 being conducted?
This trial has 20 study locations across Arizona, Florida, Georgia, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01439282's enrollment target sits among peer trials
77 670th of 1224 higher than 553 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.
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