Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

Sponsor
Eisai Co., Ltd.
Study ID
NCT02225470
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is designed as an open-label randomized parallel two-arm multicenter efficacy, pharmacokinetics and safety study of intravenously administered eribulin versus intravenously administered vinorelbine in Chinese population. Eligible female subjects will have measurable disease according to RECIST 1.1 with the modification that chest x-ray cannot be used for assessment of disease.

Key Dates

Start date
Sep 26, 2013
Status verified
Dec 2017
Primary completion
Sep 29, 2017
Completion
Jun 22, 2018

Study Design

Enrollment
530 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A, E7389 (Eribulin Mesylate)
    The eribulin mesylate dose will be 1.4 mg/m2 administered as an intravenous bolus over 2 to 5 minutes on Days 1 and 8 of each 21-day cycle.
  • Active Comparator: Arm B, Vinorelbine injection
    The vinorelbine dose will be 25 mg/m2 administered as an intravenous bolus on Days 1, 8, and 15 of each 21-day treatment cycle.

Primary Outcome Measure

Progression-Free Survival (PFS) of Eribulin Arm by tumor assessment : Time to disease progression [ Time Frame: Baseline until date of recorded disease progression or death, or up to 2 years ]

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