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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 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.

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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.

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

FieldValue
Enrollment Target 77 participants
Start Date 2011-08
Est. Completion 2014-05
Phase Phase 2

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT01439282

The ClinicalTrials.gov registry entry for NCT01439282 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.