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COMPLETED Phase 2

Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer

NCT01439282 · View on ClinicalTrials.gov ↗

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

71 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01439282

The ClinicalTrials.gov registry entry for NCT01439282 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01439282 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Texas, Arizona, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01439282?

The interventions under investigation include: capecitabine (DRUG), eribulin mesylate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01439282?

This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial