Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
- Conditions
- Breast CancerBreast TumorsHER2-Negative Breast CancerTriple Negative Breast CancerCancer of Breast
- Interventions
- Drug: E7389 (Eribulin Mesylate)
- Registration Number
- NCT02225470
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 530
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A, E7389 (Eribulin Mesylate) 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. Arm B, Vinorelbine injection 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 Measures
Name Time Method Progression-Free Survival (PFS) of Eribulin Arm by tumor assessment : Time to disease progression Baseline until date of recorded disease progression or death, or up to 2 years Time at which the highest drug concentration occurs (tmax) of Eribulin Arm in a minimum of 15 subjects Day 1 and Day 8 Progression-Free Survival (PFS) of Vinorelbine Arm by tumor assessment: Time to disease progression Baseline until date of recorded disease progression or death, or up to 2 years Maximum observed plasma concentration (Cmax) of Eribulin Arm in a minimum of 15 subjects Day 1 and Day 8 Total clearance (CL) of Eribulin Arm in a minimum of 15 subjects Day 1 and Day 8 Area under the plasma concentration-time curve (AUC) of Eribulin Arm in a minimum of 15 subjects Day 1 and Day 8 Terminal phase rate constant (lambda Z) of Eribulin Arm in a minimum of 15 subjects Day 1 and Day 8 Terminal elimination phase half-life (t1/2) of Eribulin Arm in a minimum of 15 subjects Day 1 and Day 8 Distribution volume at steady-state (Vss) of Eribulin Arm in a minimum of 15 subjects Day 1 and Day 8
- Secondary Outcome Measures
Name Time Method Evaluate safety parameters such as electrocardiograms Baseline until date of recorded disease progression or death Duration of Response Baseline until date of recorded disease progression or death or up to 5 years Evaluate safety parameters such as adverse events (AEs) Baseline until date of recorded disease progression or death Objective Response Rate (ORR) Baseline until date of recorded disease progression or death, or up to 5 years Evaluate safety assessments parameters such as vital signs( VS) Baseline until date of recorded disease progression or death Evaluate safety parameters such as laboratory measurements Baseline until date of recorded disease progression or death Overall Survival (OS) Baseline until date of death, or up 5 years
Trial Locations
- Locations (35)
04 Eisai Trial Site
🇨🇳Bengbu, Anhui, China
37 Eisai Trial Site
🇨🇳Hefei, Anhui, China
01 Eisai Trial Site
🇨🇳Beijing, Beijing, China
03 Eisai Trial Site
🇨🇳Beijing, Beijing, China
33 Eisai Trial Site
🇨🇳Beijing, Beijing, China
35 Eisai Trial Site
🇨🇳Beijing, Beijing, China
07 Eisai Trial Site
🇨🇳Fuzhou, Fujian, China
08 Eisai Trial Site
🇨🇳Fuzhou, Fujian, China
20 Eisai Trial Site
🇨🇳Guangzhou, Guangdong, China
36 Eisai Trial Site
🇨🇳Guangzhou, Guangdong, China
Scroll for more (25 remaining)04 Eisai Trial Site🇨🇳Bengbu, Anhui, China