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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 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.

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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.

Conditions Studied

Metastatic Breast Cancer

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

FieldValue
Enrollment Target 127 participants
Start Date 2011-09-23
Est. Completion 2017-04-03
Phase Phase 2

Sponsor

SCRI Development Innovations

146 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01401959

The ClinicalTrials.gov registry entry for NCT01401959 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (38% lower). The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.

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 reports 18 study locations spanning 11 distinct geographic areas - top geographies include 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.

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

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.