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E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

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ClinicalTrials.gov Identifier: NCT00337103
Recruitment Status : Completed
First Posted : June 15, 2006
Results First Posted : September 30, 2013
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: Eribulin Mesylate
Drug: Capecitabine
Enrollment 1276
Recruitment Details  
Pre-assignment Details A total of 1276 participants were enrolled and screened, of which 174 were screen failures and 1102 were randomized in the study. Of the randomized participants, 1090 participants received the study treatment.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description Eribulin mesylate 1.4 milligram per meter square (mg/m^2) intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days. Capecitabine : Capecitabine 2.5 gram per meter square per day (g/m^2/day) administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Period Title: Overall Study
Started 554 548
Treated (Safety Population) 544 546
Completed 0 0
Not Completed 554 548
Reason Not Completed
Progressive Disease             414             410
Adverse Event             45             59
Subject Choice             34             27
Clinical Progression             27             24
Physician Decision             15             14
Withdrawal by Subject             8             5
Other             5             6
Entry Criteria Not Met             4             1
Lost to Follow-up             1             2
Death             1             0
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day Total
Hide Arm/Group Description Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days. Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days. Total of all reporting groups
Overall Number of Baseline Participants 554 548 1102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 554 participants 548 participants 1102 participants
53.8  (10.37) 52.8  (10.20) 53.3  (10.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 554 participants 548 participants 1102 participants
Female
554
 100.0%
548
 100.0%
1102
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 554 participants 548 participants 1102 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
18
   3.2%
18
   3.3%
36
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
   2.7%
16
   2.9%
31
   2.8%
White
496
  89.5%
495
  90.3%
991
  89.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
25
   4.5%
19
   3.5%
44
   4.0%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description OS was measured from the date of randomization until the date of death from any cause, or the last date the participant was known to be alive. Participants who were lost to follow-up or who were alive at the date of data cutoff were censored. The censoring rules for OS were as follows: 1) if the participant was still alive at data cutoff, the date of data cutoff was considered the end date, and 2) if the participant was lost to follow-up before data cutoff, the date they were last known to be alive was considered the end date. Participants who survived past the end of the study were counted as in the full study period. If death occurred after data cutoff, the end date was to be censored at the time of data cutoff.
Time Frame From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using the Intent-to-Treat (ITT) Population defined as all participants who were randomized.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Overall Number of Participants Analyzed 554 548
Median (95% Confidence Interval)
Unit of Measure: days
484
(462 to 536)
440
(400 to 487)
2.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the time (in days) from the date of randomization to the date of the first sign of disease progression based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (v 1.1) or date of death, regardless of cause. Disease progression was measured by computed tomography (CT) and magnetic resonance imaging (MRI) performed on lesions targeted at baseline for tumor assessment. Disease progression (as assessed by independent review of the imaging scans) per RECIST v 1.1 was defined as at least a 20% increase in the sum of the diameters of the target lesions (taking as reference the smallest sum on study, including the baseline sum if that is the smallest), and an absolute increase of at least 5 millimeter (mm). Note that the appearance of one or more new lesions was also considered as disease progression.
Time Frame From date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date of 12 Mar 2012 or up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using the ITT Population defined as all participants who were randomized.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Overall Number of Participants Analyzed 554 548
Median (95% Confidence Interval)
Unit of Measure: Days
126
(106 to 131)
129
(120 to 147)
3.Secondary Outcome
Title Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for the Treatment of Cancer Quality of Life Core Questionnaire Scores Based on Core 30 Items (EORTC-QLQ-C30) at Week 6
Hide Description EORTC-QLQ-C30:cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items(dyspnoea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each of these 28 questions assessed on 4-point scale(1=not at all, 2=a little, 3=quite a bit, 4=very much); functional scales: higher score=better level of functioning; symptom scale: higher score=more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using the ITT Population defined as all participants who were randomized. Here,"overall number of participants analyzed" are the participants who were evaluable for this outcome measure.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Overall Number of Participants Analyzed 438 406
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.1  (19.23) 1.7  (20.69)
4.Secondary Outcome
Title Change From Baseline in European Organization for the Treatment of Cancer Quality of Life Core Questionnaire Scores Based on Breast Cancer Specific 23 Items (EORTC-QLQ- BR 23) at Week 6
Hide Description EORTC-QLQ-BR23:disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess quality of life of participants with breast cancer. The scores from 23 items of QLQ-BR23 included functional scales (body image, sexual functioning, sexual enjoyment, future perspective), symptom scales (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss). Each item was rated on a scale of 1 to 4 to record level of intensity (1= not at all, 2= a little, 3= quite a bit, 4= very much) within each scales. Scores averaged and transformed to 0-100 scale. High score indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using the ITT Population defined as all participants who were randomized. Here,"number analyzed" signifies the participants who were evaluable for this outcome measure for individual row.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Overall Number of Participants Analyzed 554 548
Mean (Standard Deviation)
Unit of Measure: units on a scale
Body Image Number Analyzed 441 participants 411 participants
0.7  (21.26) 4.8  (21.80)
Sexual functioning Number Analyzed 418 participants 381 participants
1.2  (14.75) -0.1  (16.62)
Sexual enjoyment Number Analyzed 82 participants 96 participants
0.8  (21.58) 3.1  (17.49)
Future perspective Number Analyzed 439 participants 410 participants
7.7  (28.48) 10.0  (30.84)
Systemic therapy side effects Number Analyzed 440 participants 415 participants
4.5  (15.55) -1.2  (14.73)
Breast Symptoms Number Analyzed 434 participants 407 participants
-3.4  (16.55) -3.6  (16.20)
Arm Symptoms Number Analyzed 437 participants 411 participants
-4.2  (17.94) -3.4  (18.65)
Upset by hair loss Number Analyzed 91 participants 56 participants
-4.4  (32.66) -10.1  (29.76)
5.Secondary Outcome
Title Objective Response Rate (ORR): Independent Review
Hide Description ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v 1.1). CR is defined as disappearance of all target legions and non-target lesions. All pathological lymph nodes (whether target and non-target), must have reduction in their short axis to less than 10 mm. PR is defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
Time Frame From date of randomization until date of first documentation of CR or PR, assessed up to data cutoff date of 12 Mar 2012 or up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using the ITT Population defined as all participants who were randomized.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Overall Number of Participants Analyzed 554 548
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.0
(8.5 to 13.9)
11.5
(8.9 to 14.5)
6.Secondary Outcome
Title Duration of Response (DOR): Independent Review
Hide Description DOR was defined as the time from first documented CR or PR until disease progression or death from any cause for those participants with a confirmed PR or CR measured by RECIST v1.1. CR defined as disappearance of all target and non-target lesions. All pathological lymph nodes(whether target and non-target), must have reduction in their short axis to less than 10 mm. PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
Time Frame From first documented CR or PR until date of recurrent or progressive disease or death, assessed up to data cutoff of date of 12 Mar 2012 or up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using for a subset of participants in the ITT Population who had a response. Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
Overall Number of Participants Analyzed 61 63
Median (95% Confidence Interval)
Unit of Measure: days
198
(150 to 273)
330
(208 to 541)
7.Secondary Outcome
Title Overall Survival Rate
Hide Description One-, two-, and three- year's survival rates were defined as the percentage of participants who were alive at one, two, and three years respectively, and estimated using the Kaplan-Meier method and Greenwood Formula.
Time Frame From the date of randomization to Year 1, 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using the ITT Population defined as all participants who were randomized.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Overall Number of Participants Analyzed 554 548
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
At 1-year
0.644
(0.604 to 0.684)
0.580
(0.538 to 0.622)
At 2-years
0.328
(0.289 to 0.368)
0.298
(0.259 to 0.337)
At 3-years
0.178
(0.144 to 0.212)
0.145
(0.113 to 0.177)
8.Secondary Outcome
Title Change From Baseline in Pain Intensity by Visual Analog Scale (VAS) Until 30 Days After the Last Dose of Study Drug
Hide Description Pain intensity was measured by marking a single vertical line that crosses a 1-100 mm unmarked VAS scale. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. A negative change score indicated improvement.
Time Frame First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using the ITT Population defined as all participants who were randomized. Here, "overall number of participants analyzed" are the participants who were evaluable for the outcome measure.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Overall Number of Participants Analyzed 431 431
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.7  (22.80) 0.4  (22.90)
9.Secondary Outcome
Title Number of Participants With Consumption of Analgesics During the Study
Hide Description Participants took analgesics as concomitant pain medications which are defined as pain medications that (1) started before the first dose of study drug and were continuing at the time of the first dose of study drug, or (2) started on/after the day of the first dose of study drug up to 30 days after the last dose of study drug medication
Time Frame First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using safety population defined as all participants who received at least one dose of study treatment.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Overall Number of Participants Analyzed 544 546
Measure Type: Count of Participants
Unit of Measure: Participants
222
  40.8%
196
  35.9%
10.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description TEAEs included both SAEs as well as non-SAEs.
Time Frame First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using safety population defined as all participants who received at least one dose of study treatment.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
Overall Number of Participants Analyzed 544 546
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
512
  94.1%
494
  90.5%
SAEs
95
  17.5%
115
  21.1%
11.Secondary Outcome
Title Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Parameter Values
Hide Description [Not Specified]
Time Frame First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using safety population defined as all participants who received at least one dose of study treatment.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Overall Number of Participants Analyzed 544 546
Measure Type: Count of Participants
Unit of Measure: Participants
362
  66.5%
224
  41.0%
12.Secondary Outcome
Title Number of Participants Who Took at Least One Concomitant Medication
Hide Description Concomitant medications included medications that either (1) started before the first dose of study drug and were continuing at the time of the first dose of study drug, or (2) started on or after the first dose of study drug up to 30 days after the last dose of study drug.
Time Frame First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using safety population defined as all participants who received at least one dose of study treatment.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Overall Number of Participants Analyzed 544 546
Measure Type: Count of Participants
Unit of Measure: Participants
496
  91.2%
483
  88.5%
13.Secondary Outcome
Title Duration of Eribulin Mesylate Exposure
Hide Description Data have been reported per primary analysis completion stage and final analysis completion stage. After primary analysis completion (at cutoff date of 12 March 2012), only 10 participants were still receiving study treatment.
Time Frame Up to approximately 6 years for primary analysis completion stage, Up to approximately 6 years 2 months for final analysis completion stage
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed using safety population defined as all participants who received at least one dose of study treatment. Here, "number analyzed" signifies the participants who were evaluable at individual stage for this outcome measure.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
Overall Number of Participants Analyzed 544 546
Median (Full Range)
Unit of Measure: days
At primary analysis completion stage Number Analyzed 544 participants 546 participants
125.0
(21 to 1372)
119.0
(21 to 1442)
At final analysis completion stage Number Analyzed 5 participants 5 participants
1743.0
(1561 to 2219)
1506.0
(1175 to 2296)
14.Secondary Outcome
Title Plasma Concentrations of Eribulin Mesylate
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1: 5-10 minutes(min), 15-30 min, 30-60 min, 60-90 min, 2-4 hours(hrs), 4-8 hrs, 10-24 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs after the start of infusion of Eribulin mesylate (Duration of each cycle is 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all participants who have received at least one dose of E7389 and have at least one quantifiable E7389 concentration. Here, "number analyzed" signifies the participants who were evaluable for this outcome measure for given time points.
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Overall Number of Participants Analyzed 173
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
5-10 minutes Number Analyzed 172 participants
415.8  (719.5)
15-30 minutes Number Analyzed 57 participants
152.6  (70.51)
30-60 minutes Number Analyzed 58 participants
95.5  (87.90)
60-90 minutes Number Analyzed 58 participants
52.7  (79.33)
2-4 hours Number Analyzed 85 participants
20.7  (32.81)
4-8 hours Number Analyzed 78 participants
10.0  (5.40)
10-24 hours Number Analyzed 44 participants
5.8  (3.72)
48-72 hours Number Analyzed 40 participants
3.7  (2.58)
72-96 hours Number Analyzed 37 participants
2.4  (1.60)
96-120 hours Number Analyzed 41 participants
7.6  (38.75)
Time Frame First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Adverse Event Reporting Description Data was analyzed using Safety Population defined as all participants who received at least one dose of study treatment.
 
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Hide Arm/Group Description Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
All-Cause Mortality
Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   442/544 (81.25%)   459/546 (84.07%) 
Hide Serious Adverse Events
Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   95/544 (17.46%)   115/546 (21.06%) 
Blood and lymphatic system disorders     
Neutropenia † 1  10/544 (1.84%)  1/546 (0.18%) 
Febrile Neutropenia † 1  7/544 (1.29%)  4/546 (0.73%) 
Leukopenia † 1  4/544 (0.74%)  0/546 (0.00%) 
Anaemia † 1  3/544 (0.55%)  0/546 (0.00%) 
Pancytopenia † 1  1/544 (0.18%)  1/546 (0.18%) 
Thrombocytopenia † 1  0/544 (0.00%)  1/546 (0.18%) 
Cardiac disorders     
Cardiopulmonary Failure † 1  1/544 (0.18%)  1/546 (0.18%) 
Myocardial Infarction † 1  1/544 (0.18%)  1/546 (0.18%) 
Pericardial Effusion † 1  1/544 (0.18%)  1/546 (0.18%) 
Angina Pectoris † 1  1/544 (0.18%)  0/546 (0.00%) 
Left Ventricular Dysfunction † 1  1/544 (0.18%)  0/546 (0.00%) 
Tachycardia † 1  1/544 (0.18%)  0/546 (0.00%) 
Cardiac Failure † 1  0/544 (0.00%)  2/546 (0.37%) 
Acute Myocardial Infarction † 1  0/544 (0.00%)  1/546 (0.18%) 
Bradycardia † 1  0/544 (0.00%)  1/546 (0.18%) 
Cardiac Tamponade † 1  0/544 (0.00%)  1/546 (0.18%) 
Cardio-respiratory Arrest † 1  0/544 (0.00%)  1/546 (0.18%) 
Cardiogenic Shock † 1  0/544 (0.00%)  1/546 (0.18%) 
Ear and labyrinth disorders     
Vertigo † 1  1/544 (0.18%)  0/546 (0.00%) 
Gastrointestinal disorders     
Vomiting † 1  2/544 (0.37%)  9/546 (1.65%) 
Abdominal Pain † 1  2/544 (0.37%)  1/546 (0.18%) 
Diarrhoea † 1  1/544 (0.18%)  15/546 (2.75%) 
Nausea † 1  1/544 (0.18%)  7/546 (1.28%) 
Gastrointestinal Haemorrhage † 1  1/544 (0.18%)  0/546 (0.00%) 
Haematemesis † 1  1/544 (0.18%)  0/546 (0.00%) 
Haematochezia † 1  1/544 (0.18%)  0/546 (0.00%) 
Haemorrhoids † 1  1/544 (0.18%)  0/546 (0.00%) 
Intestinal Ischaemia † 1  1/544 (0.18%)  0/546 (0.00%) 
Dysphagia † 1  0/544 (0.00%)  2/546 (0.37%) 
Constipation † 1  0/544 (0.00%)  1/546 (0.18%) 
Intestinal Obstruction † 1  1/544 (0.18%)  0/546 (0.00%) 
Stomatitis † 1  1/544 (0.18%)  1/546 (0.18%) 
General disorders     
Pyrexia † 1  3/544 (0.55%)  5/546 (0.92%) 
Asthenia † 1  3/544 (0.55%)  4/546 (0.73%) 
Fatigue † 1  3/544 (0.55%)  4/546 (0.73%) 
Death † 1  2/544 (0.37%)  2/546 (0.37%) 
General Physical Health Deterioration † 1  2/544 (0.37%)  3/546 (0.55%) 
Multi-Organ Failure † 1  1/544 (0.18%)  2/546 (0.37%) 
Extravasation † 1  1/544 (0.18%)  0/546 (0.00%) 
Influenza Like Illness † 1  1/544 (0.18%)  0/546 (0.00%) 
Sudden Death † 1  1/544 (0.18%)  0/546 (0.00%) 
Mucosal Inflammation † 1  0/544 (0.00%)  2/546 (0.37%) 
Generalized Edema † 1  0/544 (0.00%)  1/546 (0.18%) 
Injection Site Extravasation † 1  0/544 (0.00%)  1/546 (0.18%) 
Oedema Peripheral † 1  0/544 (0.00%)  1/546 (0.18%) 
Hepatobiliary disorders     
Hepatitis Toxic † 1  1/544 (0.18%)  0/546 (0.00%) 
Hepatic Failure † 1  1/544 (0.18%)  1/546 (0.18%) 
Cholelithiasis † 1  1/544 (0.18%)  0/546 (0.00%) 
Immune system disorders     
Hypersensitivity † 1  1/544 (0.18%)  1/546 (0.18%) 
Infections and infestations     
Pneumonia † 1  4/544 (0.74%)  4/546 (0.73%) 
Sepsis † 1  2/544 (0.37%)  4/546 (0.73%) 
Bronchopneumonia † 1  1/544 (0.18%)  1/546 (0.18%) 
Hepatitis C † 1  1/544 (0.18%)  0/546 (0.00%) 
Lung Infection † 1  1/544 (0.18%)  0/546 (0.00%) 
Pneumonia Klebsiella † 1  1/544 (0.18%)  0/546 (0.00%) 
Respiratory Tract Infection † 1  1/544 (0.18%)  0/546 (0.00%) 
Soft Tissue Infection † 1  1/544 (0.18%)  0/546 (0.00%) 
Upper Respiratory Tract Infection † 1  1/544 (0.18%)  0/546 (0.00%) 
Urinary Tract Infection † 1  1/544 (0.18%)  0/546 (0.00%) 
Bronchitis † 1  0/544 (0.00%)  3/546 (0.55%) 
Cellulitis † 1  0/544 (0.00%)  2/546 (0.37%) 
Staphylococcal Infection † 1  0/544 (0.00%)  1/546 (0.18%) 
Subcutaneous Abscess † 1  0/544 (0.00%)  1/546 (0.18%) 
Injury, poisoning and procedural complications     
Femur Fracture † 1  1/544 (0.18%)  2/546 (0.37%) 
Accidental Overdose † 1  1/544 (0.18%)  1/546 (0.18%) 
Femoral Neck Fracture † 1  1/544 (0.18%)  1/546 (0.18%) 
Hip Fracture † 1  1/544 (0.18%)  0/546 (0.00%) 
Humerus Fracture † 1  1/544 (0.18%)  0/546 (0.00%) 
Lumbar Vertebral Fracture † 1  1/544 (0.18%)  0/546 (0.00%) 
Joint Dislocation † 1  0/544 (0.00%)  1/546 (0.18%) 
Investigations     
Haemoglobin Decreased † 1  1/544 (0.18%)  0/546 (0.00%) 
Aspartate Aminotransferase Increased † 1  0/544 (0.00%)  1/546 (0.18%) 
Hepatic Enzyme Increased † 1  0/544 (0.00%)  1/546 (0.18%) 
Troponin Increased † 1  0/544 (0.00%)  1/546 (0.18%) 
Metabolism and nutrition disorders     
Dehydration † 1  1/544 (0.18%)  9/546 (1.65%) 
Hyperglycaemia † 1  1/544 (0.18%)  2/546 (0.37%) 
Decreased Appetite † 1  1/544 (0.18%)  1/546 (0.18%) 
Hypercalcaemia † 1  1/544 (0.18%)  1/546 (0.18%) 
Electrolyte Imbalance † 1  0/544 (0.00%)  1/546 (0.18%) 
Hypokalaemia † 1  0/544 (0.00%)  1/546 (0.18%) 
Hyponatraemia † 1  0/544 (0.00%)  1/546 (0.18%) 
Musculoskeletal and connective tissue disorders     
Back Pain † 1  2/544 (0.37%)  0/546 (0.00%) 
Muscular Weakness † 1  1/544 (0.18%)  0/546 (0.00%) 
Pathological Fracture † 1  1/544 (0.18%)  0/546 (0.00%) 
Arthralgia † 1  0/544 (0.00%)  1/546 (0.18%) 
Bone Pain † 1  0/544 (0.00%)  1/546 (0.18%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm Malignant † 1  7/544 (1.29%)  4/546 (0.73%) 
Metastases to Liver † 1  1/544 (0.18%)  1/546 (0.18%) 
Metastases to Meninges † 1  1/544 (0.18%)  0/546 (0.00%) 
Metastases to Ovary † 1  1/544 (0.18%)  0/546 (0.00%) 
Metastases to Peritoneum † 1  1/544 (0.18%)  0/546 (0.00%) 
Oncologic Complication † 1  0/544 (0.00%)  2/546 (0.37%) 
Tumour Pain † 1  0/544 (0.00%)  2/546 (0.37%) 
Malignant Ascites † 1  0/544 (0.00%)  1/546 (0.18%) 
Malignant Pleural Effusion † 1  0/544 (0.00%)  1/546 (0.18%) 
Metastases to Central Nervous System † 1  0/544 (0.00%)  1/546 (0.18%) 
Metastases to Pleura † 1  0/544 (0.00%)  1/546 (0.18%) 
Rectal Cancer † 1  0/544 (0.00%)  1/546 (0.18%) 
Nervous system disorders     
Headache † 1  2/544 (0.37%)  4/546 (0.73%) 
Cerebrovascular Accident † 1  2/544 (0.37%)  2/546 (0.37%) 
Spinal Cord Compression † 1  2/544 (0.37%)  2/546 (0.37%) 
Convulsion † 1  1/544 (0.18%)  2/546 (0.37%) 
Dizziness † 1  1/544 (0.18%)  0/546 (0.00%) 
Facial Paresis † 1  1/544 (0.18%)  0/546 (0.00%) 
Myoclonic Epilepsy † 1  1/544 (0.18%)  0/546 (0.00%) 
Partial Seizures † 1  1/544 (0.18%)  0/546 (0.00%) 
Peripheral Motor Neuropathy † 1  1/544 (0.18%)  0/546 (0.00%) 
Peripheral Sensory Neuropathy † 1  1/544 (0.18%)  0/546 (0.00%) 
Syncope † 1  1/544 (0.18%)  0/546 (0.00%) 
Transient Ischaemic Attack † 1  1/544 (0.18%)  0/546 (0.00%) 
Depressed Level of Consciousness † 1  0/544 (0.00%)  2/546 (0.37%) 
Aphasia † 1  0/544 (0.00%)  1/546 (0.18%) 
Cerebellar Infarction † 1  0/544 (0.00%)  1/546 (0.18%) 
Coma Hepatic † 1  0/544 (0.00%)  1/546 (0.18%) 
Dysgeuesia † 1  0/544 (0.00%)  1/546 (0.18%) 
Intracranial Pressure Increased † 1  0/544 (0.00%)  1/546 (0.18%) 
Lethargy † 1  0/544 (0.00%)  1/546 (0.18%) 
Simple Partial Seizures † 1  0/544 (0.00%)  1/546 (0.18%) 
Somnolence † 1  0/544 (0.00%)  1/546 (0.18%) 
Psychiatric disorders     
Confusional State † 1  2/544 (0.37%)  0/546 (0.00%) 
Mental status changes † 1  2/544 (0.37%)  1/546 (0.18%) 
Renal and urinary disorders     
Renal Failure † 1  1/544 (0.18%)  1/546 (0.18%) 
Renal Failure Acute † 1  1/544 (0.18%)  1/546 (0.18%) 
Haematuria † 1  0/544 (0.00%)  1/546 (0.18%) 
Hydronephrosis † 1  0/544 (0.00%)  1/546 (0.18%) 
Reproductive system and breast disorders     
Vaginal Haemorrhage † 1  0/544 (0.00%)  1/546 (0.18%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1  13/544 (2.39%)  17/546 (3.11%) 
Respiratory Failure † 1  5/544 (0.92%)  7/546 (1.28%) 
Pleural Effusion † 1  2/544 (0.37%)  2/546 (0.37%) 
Pulmonary Embolism † 1  1/544 (0.18%)  3/546 (0.55%) 
Hydrothorax † 1  1/544 (0.18%)  2/546 (0.37%) 
Acute Respiratory Failure † 1  1/544 (0.18%)  1/546 (0.18%) 
Epistaxis † 1  1/544 (0.18%)  0/546 (0.00%) 
Tracheal Stenosis † 1  1/544 (0.18%)  0/546 (0.00%) 
Respiratory Distress † 1  0/544 (0.00%)  2/546 (0.37%) 
Cough † 1  0/544 (0.00%)  1/546 (0.18%) 
Dyspnoea Exertional † 1  0/544 (0.00%)  1/546 (0.18%) 
Pneumothorax † 1  0/544 (0.00%)  1/546 (0.18%) 
Wheezing † 1  0/544 (0.00%)  1/546 (0.18%) 
Skin and subcutaneous tissue disorders     
Palmar-Plantar Erythrodysaesthesia † 1  0/544 (0.00%)  2/546 (0.37%) 
Surgical and medical procedures     
Malignant Breast Lump Removal † 1  0/544 (0.00%)  1/546 (0.18%) 
Vascular disorders     
Deep Vein Thrombosis † 1  2/544 (0.37%)  3/546 (0.55%) 
Hypotension † 1  1/544 (0.18%)  1/546 (0.18%) 
Thrombophlebitis † 1  1/544 (0.18%)  0/546 (0.00%) 
Hypertension † 1  0/544 (0.00%)  1/546 (0.18%) 
Shock Haemorrhagic † 1  0/544 (0.00%)  1/546 (0.18%) 
Thrombosis † 1  0/544 (0.00%)  1/546 (0.18%) 
Haemorrhage † 1  0/544 (0.00%)  1/546 (0.18%) 
1
Term from vocabulary, MedDRA 14.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eribulin Mesylate 1.4 mg/m^2 Capecitabine 2.5 g/m^2/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   509/544 (93.57%)   489/546 (89.56%) 
Blood and lymphatic system disorders     
Neutropenia † 1  292/544 (53.68%)  87/546 (15.93%) 
Leukopenia † 1  171/544 (31.43%)  57/546 (10.44%) 
Anaemia † 1  102/544 (18.75%)  96/546 (17.58%) 
Thrombocytopenia † 1  27/544 (4.96%)  29/546 (5.31%) 
Gastrointestinal disorders     
Nausea † 1  121/544 (22.24%)  131/546 (23.99%) 
Diarrhoea † 1  77/544 (14.15%)  154/546 (28.21%) 
Vomiting † 1  63/544 (11.58%)  89/546 (16.30%) 
Constipation † 1  42/544 (7.72%)  46/546 (8.42%) 
Abdominal Pain † 1  32/544 (5.88%)  46/546 (8.42%) 
Abdominal Pain Upper † 1  31/544 (5.70%)  39/546 (7.14%) 
Stomatitis † 1  27/544 (4.96%)  31/546 (5.68%) 
General disorders     
Fatigue † 1  91/544 (16.73%)  82/546 (15.02%) 
Asthenia † 1  83/544 (15.26%)  79/546 (14.47%) 
Pyrexia † 1  67/544 (12.32%)  27/546 (4.95%) 
Oedema Peripheral † 1  35/544 (6.43%)  36/546 (6.59%) 
Mucosal Inflammation † 1  26/544 (4.78%)  35/546 (6.41%) 
Hepatobiliary disorders     
Hyperbilirubinaemia † 1  9/544 (1.65%)  38/546 (6.96%) 
Infections and infestations     
Urinary Tract Infection † 1  29/544 (5.33%)  26/546 (4.76%) 
Investigations     
Alanine Aminotransferase Increased † 1  47/544 (8.64%)  23/546 (4.21%) 
Aspartate Aminotransferase Increased † 1  43/544 (7.90%)  27/546 (4.95%) 
Metabolism and nutrition disorders     
Decreased Appetite † 1  68/544 (12.50%)  80/546 (14.65%) 
Musculoskeletal and connective tissue disorders     
Back Pain † 1  55/544 (10.11%)  43/546 (7.88%) 
Bone Pain † 1  50/544 (9.19%)  42/546 (7.69%) 
Pain in Extremity † 1  47/544 (8.64%)  37/546 (6.78%) 
Arthralgia † 1  42/544 (7.72%)  31/546 (5.68%) 
Myalgia † 1  30/544 (5.51%)  8/546 (1.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour Pain † 1  29/544 (5.33%)  22/546 (4.03%) 
Nervous system disorders     
Peripheral Sensory Neuropathy † 1  73/544 (13.42%)  38/546 (6.96%) 
Headache † 1  67/544 (12.32%)  55/546 (10.07%) 
Dizziness † 1  30/544 (5.51%)  29/546 (5.31%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1  49/544 (9.01%)  51/546 (9.34%) 
Cough † 1  45/544 (8.27%)  44/546 (8.06%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1  188/544 (34.56%)  22/546 (4.03%) 
Palmar-Plantar Erythrodysaesthesia Syndrome † 1  1/544 (0.18%)  244/546 (44.69%) 
1
Term from vocabulary, MedDRA 14.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eisai Medical Information
Organization: Eisai Inc.
Phone: 1-888-274-2378
EMail: esi_oncmedinfo@eisai.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00337103    
Other Study ID Numbers: E7389-G000-301
First Submitted: June 13, 2006
First Posted: June 15, 2006
Results First Submitted: July 31, 2013
Results First Posted: September 30, 2013
Last Update Posted: June 18, 2020