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

Phase 3

Completed

• Conditions: Breast Cancer; Breast Tumors; HER2-Negative Breast Cancer; Triple Negative Breast Cancer; Cancer of Breast
• Interventions: Drug: E7389 (Eribulin Mesylate); Drug: Vinorelbine injection

• 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

Study Timeline

• Study Start: 2013-09-26
• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-26
• Primary Completion: 2017-09-29
• Status Verified: 2017-12
• Study Completion: 2018-06-22
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 530

Inclusion Criteria

Not provided

Exclusion Criteria

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
Overall Survival (OS)	Baseline until date of death, or up 5 years
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

Trial Locations

Locations (35)

33 Eisai Trial Site; 🇨🇳 Beijing, Beijing, China

10 Eisai Trial Site; 🇨🇳 Nanning, Guangxi, China

20 Eisai Trial Site; 🇨🇳 Guangzhou, Guangdong, China

15 Eisai Trial Site; 🇨🇳 Wuhan, Hubei, China

13 Eisai Trial Site; 🇨🇳 Changsha, Hunan, China

31 Eisai Trial Site; 🇨🇳 Nanjing, Jiangsu, China

06 Eisai Trial Site; 🇨🇳 Dalian, Liaoning, China

28 Eisai Trial Site; 🇨🇳 Xi'an, Shaanxi, China

24 Eisai Trial Site; 🇨🇳 Xian, Shaanxi, China

22 Eisai Trial Site; 🇨🇳 Qingdao, Shandong, China

23 Eisai Trial Site; 🇨🇳 Taiyuan, Shanxi, China

09 Eisai Trial Site; 🇨🇳 Shanghai, Shanghai, China

26 Eisai Trial Site; 🇨🇳 Chengtu, Sichuan, China

30 Eisai Trial Site; 🇨🇳 Yunnan, Yunnan, China

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

35 Eisai Trial Site; 🇨🇳 Beijing, Beijing, China

07 Eisai Trial Site; 🇨🇳 Fuzhou, Fujian, China

08 Eisai Trial Site; 🇨🇳 Fuzhou, Fujian, China

12 Eisai Trial Site; 🇨🇳 Shijiazhuang, Hebei, China

11 Eisai Trial Site; 🇨🇳 Harbin, Heilongjiang, China

38 Eisai Trial Site; 🇨🇳 Zhengzhou, Henan, China

36 Eisai Trial Site; 🇨🇳 Guangzhou, Guangdong, China

14 Eisai Trial Site; 🇨🇳 Wuhan, Hubei, China

05 Eisai Trial Site; 🇨🇳 Changsha, Hunan, China

34 Eisai Trial Site; 🇨🇳 Changsha, Hunan, China

18 Eisai Trial Site; 🇨🇳 Nanjing, Jiangsu, China

16 Eisai Trial Site; 🇨🇳 Changchun, Jilin, China

17 Eisai Trial Site; 🇨🇳 Changchun, Jilin, China

21 Eisai Trial Site; 🇨🇳 Yinchuang, Ningxia, China

27 Eisai Trial Site; 🇨🇳 Tianjin, Tianjin, China

40 Eisai Trial Site; 🇨🇳 Hangzhou, Zhejiang, China

19 Eisai Trial Site; 🇨🇳 Shenyang, Liaoning, China