Trial · NCT00337103
E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
NCT00337103, Phase 3, Completed, Eisai Inc.; results first posted 2013-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes. Trials, record NCT00337103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00337103
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
- NCT number
- NCT00337103
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,276 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Metastatic Breast Cancer
- Interventions
- Eribulin Mesylate, Capecitabine
- First posted
- 2006-06-15
- Last updated
- 2020-06-18
- Results first posted
- 2013-09-30
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | 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 | 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. |
| Primary | Progression Free Survival (PFS) | 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 | 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. |
| Secondary | 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 | Baseline and Week 6 | 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. |
| Secondary | 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 | Baseline and Week 6 | 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. |
| Secondary | Objective Response Rate (ORR): Independent Review | 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 | 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. |
| Secondary | Duration of Response (DOR): Independent Review | 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 | 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. |
| Secondary | Overall Survival Rate | From the date of randomization to Year 1, 2 and 3 | 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. |
| Secondary | Change From Baseline in Pain Intensity by Visual Analog Scale (VAS) Until 30 Days After the Last Dose of Study Drug | First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months) | 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. |
| Secondary | Number of Participants With Consumption of Analgesics During the Study | First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months) | 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 |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months) | TEAEs included both SAEs as well as non-SAEs. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | 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 | Data was analyzed using the Intent-to-Treat (ITT) Population defined as all participants who were randomized. | days | MEDIAN |
| PRIMARY | Progression Free Survival (PFS) | 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 | Data was analyzed using the ITT Population defined as all participants who were randomized. | Days | MEDIAN |
| SECONDARY | 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 | Baseline and Week 6 | 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. | units on a scale | MEAN |
| SECONDARY | 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 | Baseline and Week 6 | 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. | units on a scale | MEAN |
| SECONDARY | Objective Response Rate (ORR): Independent Review | 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 | Data was analyzed using the ITT Population defined as all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR): Independent Review | 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 | 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. | days | MEDIAN |
| SECONDARY | Overall Survival Rate | From the date of randomization to Year 1, 2 and 3 | Data was analyzed using the ITT Population defined as all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Pain Intensity by Visual Analog Scale (VAS) Until 30 Days After the Last Dose of Study Drug | First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months) | 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. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Consumption of Analgesics During the Study | First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months) | Data was analyzed using safety population defined as all participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months) | Data was analyzed using safety population defined as all participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Eribulin Mesylate 1.4 mg/m^2 | 484 | 95% Confidence Interval 462 to 536 | days | |
| Overall Survival (OS) | Capecitabine 2.5 g/m^2/Day | 440 | 95% Confidence Interval 400 to 487 | days | |
| Progression Free Survival (PFS) | Eribulin Mesylate 1.4 mg/m^2 | 126 | 95% Confidence Interval 106 to 131 | Days | |
| Progression Free Survival (PFS) | Capecitabine 2.5 g/m^2/Day | 129 | 95% Confidence Interval 120 to 147 | Days | |
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 | Eribulin Mesylate 1.4 mg/m^2 | 0.1 | Standard Deviation 19.23 | units on a scale | |
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 | Capecitabine 2.5 g/m^2/Day | 1.7 | Standard Deviation 20.69 | units on a scale | |
| 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 | Eribulin Mesylate 1.4 mg/m^2 | Body Image | 0.7 | Standard Deviation 21.26 | units on a scale |
| 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 | Capecitabine 2.5 g/m^2/Day | Body Image | 4.8 | Standard Deviation 21.80 | units on a scale |
| 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 | Eribulin Mesylate 1.4 mg/m^2 | Sexual functioning | 1.2 | Standard Deviation 14.75 | units on a scale |
| 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 | Capecitabine 2.5 g/m^2/Day | Sexual functioning | -0.1 | Standard Deviation 16.62 | units on a scale |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eribulin Mesylate 1.4 mg/m^2 | 554 | |
| Overall Study | STARTED | Capecitabine 2.5 g/m^2/Day | 548 | |
| Overall Study | Treated (Safety Population) | Eribulin Mesylate 1.4 mg/m^2 | 544 | |
| Overall Study | Treated (Safety Population) | Capecitabine 2.5 g/m^2/Day | 546 | |
| Overall Study | COMPLETED | Eribulin Mesylate 1.4 mg/m^2 | 0 | |
| Overall Study | COMPLETED | Capecitabine 2.5 g/m^2/Day | 0 | |
| Overall Study | NOT COMPLETED | Eribulin Mesylate 1.4 mg/m^2 | 554 | |
| Overall Study | NOT COMPLETED | Capecitabine 2.5 g/m^2/Day | 548 |
Source ClinicalTrials.gov
Adverse events364
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Eribulin Mesylate 1.4 mg/m^2 | 292 | 544 | |
| other | Neutropenia | Blood and lymphatic system disorders | Capecitabine 2.5 g/m^2/Day | 87 | 546 | |
| other | Leukopenia | Blood and lymphatic system disorders | Eribulin Mesylate 1.4 mg/m^2 | 171 | 544 | |
| other | Leukopenia | Blood and lymphatic system disorders | Capecitabine 2.5 g/m^2/Day | 57 | 546 | |
| other | Anaemia | Blood and lymphatic system disorders | Eribulin Mesylate 1.4 mg/m^2 | 102 | 544 | |
| other | Anaemia | Blood and lymphatic system disorders | Capecitabine 2.5 g/m^2/Day | 96 | 546 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Eribulin Mesylate 1.4 mg/m^2 | 27 | 544 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Capecitabine 2.5 g/m^2/Day | 29 | 546 | |
| other | Fatigue | General disorders | Eribulin Mesylate 1.4 mg/m^2 | 91 | 544 | |
| other | Fatigue | General disorders | Capecitabine 2.5 g/m^2/Day | 82 | 546 |
1 to 10 of 364Source ClinicalTrials.gov
See all 364 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eribulin Mesylate 1.4 mg/m^2 | 442 | 544 |
| Total, all-cause mortality | Capecitabine 2.5 g/m^2/Day | 459 | 546 |
| Total, other adverse events | Eribulin Mesylate 1.4 mg/m^2 | 509 | 544 |
| Total, other adverse events | Capecitabine 2.5 g/m^2/Day | 489 | 546 |
| Total, serious adverse events | Eribulin Mesylate 1.4 mg/m^2 | 95 | 544 |
| Total, serious adverse events | Capecitabine 2.5 g/m^2/Day | 115 | 546 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Eribulin Mesylate 1.4 mg/m^2 vs Capecitabine 2.5 g/m^2/Day: Number of Participants Who Took at Least One Concomitant Medication | Trial comparisons |
| Eribulin Mesylate 1.4 mg/m^2 vs Capecitabine 2.5 g/m^2/Day: deaths from any cause | Trial comparisons |
| Eribulin Mesylate 1.4 mg/m^2 vs Capecitabine 2.5 g/m^2/Day: Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Parameter Values | Trial comparisons |
| Eribulin Mesylate 1.4 mg/m^2 vs Capecitabine 2.5 g/m^2/Day: Number of Participants With Consumption of Analgesics During the Study | Trial comparisons |
| Eribulin Mesylate 1.4 mg/m^2 vs Capecitabine 2.5 g/m^2/Day: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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