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Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)

NCT01463891 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 963

Last updated 2023-07-24

No results posted yet for this study

Summary

To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer

Conditions

  • Inoperable or Recurrent Breast Cancer

Interventions

DRUG

Eribulin Mesylate

The usual adult dose of eribulin mesylate is 1.4 mg/m\^2 (body surface area) administered intravenously over 2 to 5 minutes, once daily once a week. Treatment shall be continued for 2 consecutive weeks followed by a third week of drug cessation. With each cycle lasting 3 weeks, the treatment shall be repeated. The dose may be reduced, depending on the condition of the individual patient.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Toshiyuki Matsuoka · Drug Fostering and Evolution Cordination Department, Eisai Co., Ltd.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-19
Primary Completion
2012-12-26
Completion
2013-11-27

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463891 on ClinicalTrials.gov