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Eribulin Treatment as 1st-line or 2nd-line Chemotherapy for HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer

NCT02551263 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 201

Last updated 2021-06-11

No results posted yet for this study

Summary

This is a observational study in a real-world setting, not requiring determining a dosage regimen, dose reduction criteria, rest period criteria and withdrawal criteria. The purpose of the study is to investigate the efficacy of eribulin as the first or second line chemotherapy to prolong overall survival and to explore factors affecting the survival in patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer who scheduled to receive the first or second line chemotherapy in clinical practice in Japan. The total duration of the study will be a maximum of 5 years, consisting of 2-year enrollment period and 3-year observational period; the duration of patient participation will be 3 years. All patients will receive adequate treatment for breast cancer which selected by the primary physician after enrollment using the Japanese Breast Cancer Society Clinical Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will enter patient data into an electronic data capture (EDC) system up to the third chemotherapy in the study. The end of the study is defined as the time the last patient completes observational period. Patients will primarily be assessed by overall survival (OS) of the first line chemotherapy.

Conditions

Interventions

DRUG

Eribulin

Eribulin 1.4 mg/m2 will be administered intravenously over 2 to 5 minutes on day 1 and 8 of every 21-day cycle, in a real-world setting.

Sponsors & Collaborators

  • Kyoto Breast Cancer Research Network

    collaborator OTHER

  • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

    lead OTHER

Principal Investigators

  • Yuichiro Kikawa, MD · Kobe City Medical Center General Hospital

  • Takeshi Kotake, MD · Kyoto University

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-22
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

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 NCT02551263 on ClinicalTrials.gov