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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00337103




Registration number
NCT00337103
Ethics application status
Date submitted
13/06/2006
Date registered
15/06/2006
Date last updated
18/06/2020

Titles & IDs
Public title
E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
Scientific title
A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
Secondary ID [1] 0 0
E7389-G000-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eribulin Mesylate
Treatment: Drugs - Capecitabine

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: Eribulin Mesylate
1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days

Treatment: Drugs: Capecitabine
Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
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
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline and Week 6
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline and Week 6
Secondary outcome [3] 0 0
Objective Response Rate (ORR): Independent Review
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Duration of Response (DOR): Independent Review
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Overall Survival Rate
Timepoint [5] 0 0
From the date of randomization to Year 1, 2 and 3
Secondary outcome [6] 0 0
Change From Baseline in Pain Intensity by Visual Analog Scale (VAS) Until 30 Days After the Last Dose of Study Drug
Timepoint [6] 0 0
First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Secondary outcome [7] 0 0
Number of Participants With Consumption of Analgesics During the Study
Timepoint [7] 0 0
First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Secondary outcome [8] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [8] 0 0
First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Secondary outcome [9] 0 0
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Parameter Values
Timepoint [9] 0 0
First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Secondary outcome [10] 0 0
Number of Participants Who Took at Least One Concomitant Medication
Timepoint [10] 0 0
First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Secondary outcome [11] 0 0
Duration of Eribulin Mesylate Exposure
Timepoint [11] 0 0
Up to approximately 6 years for primary analysis completion stage, Up to approximately 6 years 2 months for final analysis completion stage
Secondary outcome [12] 0 0
Plasma Concentrations of Eribulin Mesylate
Timepoint [12] 0 0
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)

Eligibility
Key inclusion criteria
1. Female patients with histologically or cytologically confirmed carcinoma of the
breast. Every effort should be made to ensure that paraffin embedded tissue or slides
from the diagnostic biopsy or surgical specimen are available for confirmation of
diagnosis.

2. Patients with locally advanced or metastatic disease who have received up to three
prior chemotherapy regimens, and no more than two prior regimens for advanced and/or
metastatic disease.

- Regimens must have included an anthracycline (e.g., doxorubicin, epirubicin) and
a taxane (e.g., paclitaxel, docetaxel), either in combination or in separate
regimens.

- Patients with known human epidermal growth factor 2 (HER2/neu) over-expressing
tumors may additionally have been treated with trastuzumab in centers where this
treatment is available.

- Patients with known estrogen and/or progesterone receptor-expressing tumors may
have additionally been treated with hormonal therapy.

3. Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or
lower, except for stable sensory neuropathy <= Grade 2 and alopecia.

4. Age >= 18 years.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

6. Life expectancy of >= 3 months.

7. Adequate renal function as evidenced by serum creatinine <1.5 mg/dL or calculated
creatinine clearance > 50 mL/minute (min) per the Cockcroft and Gault formula.

8. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x
10^9/L, hemoglobin >= 10.0 g/dL (a hemoglobin < 10.0 g/dL acceptable if it is
corrected by growth factor or transfusion), and platelet count >= 100 x 10^9/L.

9. Adequate liver function as evidenced by bilirubin <= 1.5 times the upper limits of
normal (ULN) and alkaline phosphatase, alanine transaminase (ALT), and aspartate
transaminase (AST) <= 3 x ULN (in the case of liver metastases <= 5 x ULN), or in case
of bone metastases, liver specific alkaline phosphatase <= 3 x ULN.

10. Patients willing and able to complete the EORTC (European Organization for Research on
the Treatment of Cancer) quality of life questionnaire (QLQ-C30 with breast cancer
module QLQ-BR23) and to record their pain level on the Visual Analog Scale (VAS).

11. Patients willing and able to comply with the study protocol for the duration of the
study.

12. Written informed consent prior to any study-specific screening procedures with the
understanding that the patient may withdraw consent at any time without prejudice.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have received more than three prior chemotherapy regimens for their
disease, including adjuvant therapies, or patients who have received more than two
prior chemotherapy regimens for advanced disease (other therapies are allowed e.g.,
anti-estrogens, trastuzumab and radiotherapy).

2. Patients who have received capecitabine as a prior therapy for their disease.

3. Patients who have received chemotherapy, radiation, or biological therapy within two
weeks, or hormonal therapy, within one week before study treatment start, or any
investigational drug within four weeks before study treatment start.

4. Radiation therapy encompassing > 30% of marrow.

5. Prior treatment with mitomycin C or nitrosourea.

6. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring
active treatment, including the use of oxygen.

7. Patients with brain or subdural metastases are not eligible, unless they have
completed local therapy and have discontinued the use of corticosteroids for this
indication for at least 4 weeks before starting treatment with study treatment. Any
symptoms attributed to brain metastases must be stable for at least 4 weeks before
starting study treatment; radiographic stability should be determined by comparing a
contrast-enhanced Computed Tomography Scan (CT) or Magnetic Resonance Imaging (MRI)
brain scan performed during screening to a prior scan performed at least 4 weeks
earlier.

8. Patients with meningeal carcinomatosis.

9. Patients who are receiving anti-coagulant therapy with warfarin or related compounds,
other than for line patency, and cannot be changed to heparin-based therapy, are not
eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time
(PT)/international normalized ratio (INR) must be closely monitored.

10. Women who are pregnant or breast-feeding; women of childbearing potential with either
a positive pregnancy test at screening or no pregnancy test; women of childbearing
potential unless (1) surgically sterile or (2) using adequate measures of
contraception (considered to be two methods of contraception, one of which must be a
barrier method, e.g. condom, diaphragm or cervical cap). Perimenopausal women must be
amenorrheic for at least 12 months to be considered of non-childbearing potential.

11. Severe/uncontrolled intercurrent illness/infection.

12. Significant cardiovascular impairment (history of congestive heart failure > New York
Heart Association [NYHA] Grade II, unstable angina or myocardial infarction within the
past six months, or serious cardiac arrhythmia).

13. Patients with organ allografts requiring immunosuppression.

14. Patients with known positive human immunodeficiency virus (HIV) status.

15. Patients who have had a prior malignancy, other than carcinoma in situ of the cervix,
or non-melanoma skin cancer, unless the prior malignancy was diagnosed and
definitively treated >= 5 years previously with no subsequent evidence of recurrence.

16. Patients with pre-existing neuropathy > Grade 2.

17. Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical
derivative.

18. Patients who participated in a prior E7389 clinical trial.

19. Patients with other significant disease or disorders that, in the Investigator's
opinion, would exclude the patient from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/12/2017
Sample size
Target
Accrual to date
Final
1276
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Bankstown Hospital, Oncology Trials Unit - Bankstown
Recruitment hospital [2] 0 0
- Hornsby
Recruitment hospital [3] 0 0
Liverpool Hospital, Cancer Therapy Centre - Liverpool
Recruitment hospital [4] 0 0
Ashford Cancer Centre - Adelaide
Recruitment hospital [5] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 0 0
Saint Vincent's Hospital - Fitzroy
Recruitment hospital [7] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [8] 0 0
Epworth Freemasons Hospital - East Melbourne
Recruitment hospital [9] 0 0
Sir Charles Gairdner Hospital, Dept. of Medical Oncology - Nedlands
Recruitment hospital [10] 0 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
2077 - Hornsby
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
5035 - Adelaide
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment postcode(s) [8] 0 0
- East Melbourne
Recruitment postcode(s) [9] 0 0
- Nedlands
Recruitment postcode(s) [10] 0 0
- South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maine
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Santa Fe
Country [13] 0 0
Argentina
State/province [13] 0 0
Tucuman
Country [14] 0 0
Argentina
State/province [14] 0 0
Bahia Blanca
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad Autonoma de Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad Autonoma
Country [17] 0 0
Argentina
State/province [17] 0 0
Mendoza
Country [18] 0 0
Belgium
State/province [18] 0 0
Aalst
Country [19] 0 0
Belgium
State/province [19] 0 0
Brussels
Country [20] 0 0
Belgium
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Ghent
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Belgium
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Liege
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Brazil
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Florianopolis
Country [23] 0 0
Brazil
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Ijui
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Brazil
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Jundiai
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Brazil
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Londrina
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Ribeirao Preto
Country [29] 0 0
Brazil
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Salvador
Country [30] 0 0
Brazil
State/province [30] 0 0
Santo Andre
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Paulo
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Burgas
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Gabrovo
Country [34] 0 0
Bulgaria
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Pleven
Country [35] 0 0
Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Shumen
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Sofia
Country [39] 0 0
Bulgaria
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Stara Zagora
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Varna
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Canada
State/province [43] 0 0
Montreal
Country [44] 0 0
Canada
State/province [44] 0 0
Thunder Bay
Country [45] 0 0
Czechia
State/province [45] 0 0
Ceske Budejovice
Country [46] 0 0
Czechia
State/province [46] 0 0
Olomouc
Country [47] 0 0
Czechia
State/province [47] 0 0
Prague 8
Country [48] 0 0
Czechia
State/province [48] 0 0
Zlin Poiters
Country [49] 0 0
France
State/province [49] 0 0
La Roche sur Yon
Country [50] 0 0
France
State/province [50] 0 0
Poitiers Cedex
Country [51] 0 0
France
State/province [51] 0 0
Saint Priest en Jarez
Country [52] 0 0
Germany
State/province [52] 0 0
Bochum
Country [53] 0 0
Germany
State/province [53] 0 0
Hamburg
Country [54] 0 0
Germany
State/province [54] 0 0
Homburg
Country [55] 0 0
Germany
State/province [55] 0 0
Magdeburg
Country [56] 0 0
Germany
State/province [56] 0 0
Rostock
Country [57] 0 0
Greece
State/province [57] 0 0
Patra
Country [58] 0 0
Hungary
State/province [58] 0 0
Budapest
Country [59] 0 0
Hungary
State/province [59] 0 0
Debrecen
Country [60] 0 0
Hungary
State/province [60] 0 0
Gyula
Country [61] 0 0
Hungary
State/province [61] 0 0
Pecs
Country [62] 0 0
Hungary
State/province [62] 0 0
Szeged
Country [63] 0 0
Hungary
State/province [63] 0 0
Veszprem
Country [64] 0 0
Israel
State/province [64] 0 0
Ashkelon
Country [65] 0 0
Israel
State/province [65] 0 0
Beer Sheva
Country [66] 0 0
Israel
State/province [66] 0 0
Jerusalem
Country [67] 0 0
Israel
State/province [67] 0 0
Kfar Saba
Country [68] 0 0
Israel
State/province [68] 0 0
Petach Tikva
Country [69] 0 0
Israel
State/province [69] 0 0
Rechovot
Country [70] 0 0
Israel
State/province [70] 0 0
Tel Hashomer
Country [71] 0 0
Italy
State/province [71] 0 0
Ancona
Country [72] 0 0
Italy
State/province [72] 0 0
Lugo
Country [73] 0 0
Italy
State/province [73] 0 0
Meldola
Country [74] 0 0
Italy
State/province [74] 0 0
Modena
Country [75] 0 0
Italy
State/province [75] 0 0
Pesaro
Country [76] 0 0
Italy
State/province [76] 0 0
Ravenna
Country [77] 0 0
Italy
State/province [77] 0 0
Rimini
Country [78] 0 0
Italy
State/province [78] 0 0
Sassari
Country [79] 0 0
Mexico
State/province [79] 0 0
Chihuahua
Country [80] 0 0
Mexico
State/province [80] 0 0
Monterrey
Country [81] 0 0
Mexico
State/province [81] 0 0
Morelia
Country [82] 0 0
Poland
State/province [82] 0 0
Bialystok
Country [83] 0 0
Poland
State/province [83] 0 0
Bytom
Country [84] 0 0
Poland
State/province [84] 0 0
Elblag
Country [85] 0 0
Poland
State/province [85] 0 0
Gdansk
Country [86] 0 0
Poland
State/province [86] 0 0
Krakow
Country [87] 0 0
Poland
State/province [87] 0 0
Olsztyn
Country [88] 0 0
Poland
State/province [88] 0 0
Rybnik
Country [89] 0 0
Poland
State/province [89] 0 0
Torun
Country [90] 0 0
Poland
State/province [90] 0 0
Wroclaw
Country [91] 0 0
Romania
State/province [91] 0 0
Cluj
Country [92] 0 0
Romania
State/province [92] 0 0
Bucharest
Country [93] 0 0
Romania
State/province [93] 0 0
Bucuresti
Country [94] 0 0
Romania
State/province [94] 0 0
Cluj-Napoca
Country [95] 0 0
Romania
State/province [95] 0 0
Iasi
Country [96] 0 0
Romania
State/province [96] 0 0
Sibiu
Country [97] 0 0
Romania
State/province [97] 0 0
Timisoara
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Yaroslavlr
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Barnaul
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Kazan
Country [101] 0 0
Russian Federation
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Kirov
Country [102] 0 0
Russian Federation
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Krasnodar
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Moscow
Country [104] 0 0
Russian Federation
State/province [104] 0 0
Nizhny Novgorod
Country [105] 0 0
Russian Federation
State/province [105] 0 0
Obninsk
Country [106] 0 0
Russian Federation
State/province [106] 0 0
Rostov-on-Don
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Saint Petersburg
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Saratov
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Sochi
Country [110] 0 0
Russian Federation
State/province [110] 0 0
Tomsk
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Vladimir
Country [112] 0 0
Singapore
State/province [112] 0 0
Singapore
Country [113] 0 0
South Africa
State/province [113] 0 0
Durban
Country [114] 0 0
South Africa
State/province [114] 0 0
Gaunteng
Country [115] 0 0
South Africa
State/province [115] 0 0
Pretoria
Country [116] 0 0
South Africa
State/province [116] 0 0
Cape Town
Country [117] 0 0
South Africa
State/province [117] 0 0
Johannesburg
Country [118] 0 0
South Africa
State/province [118] 0 0
Sandton
Country [119] 0 0
Spain
State/province [119] 0 0
Vizcaya
Country [120] 0 0
Spain
State/province [120] 0 0
Barcelona
Country [121] 0 0
Spain
State/province [121] 0 0
Guadalajara
Country [122] 0 0
Spain
State/province [122] 0 0
La Coruna
Country [123] 0 0
Spain
State/province [123] 0 0
Sevilla
Country [124] 0 0
Spain
State/province [124] 0 0
Valencia
Country [125] 0 0
Taiwan
State/province [125] 0 0
Changhua
Country [126] 0 0
Taiwan
State/province [126] 0 0
Taichung
Country [127] 0 0
Taiwan
State/province [127] 0 0
Tainan City
Country [128] 0 0
Taiwan
State/province [128] 0 0
Taipei
Country [129] 0 0
Taiwan
State/province [129] 0 0
Yung-Kang City
Country [130] 0 0
Ukraine
State/province [130] 0 0
Chernigov
Country [131] 0 0
Ukraine
State/province [131] 0 0
Dnepropetrovsk
Country [132] 0 0
Ukraine
State/province [132] 0 0
Donetsk
Country [133] 0 0
Ukraine
State/province [133] 0 0
Kharkov
Country [134] 0 0
Ukraine
State/province [134] 0 0
Khmelnytskyi
Country [135] 0 0
Ukraine
State/province [135] 0 0
Kiev
Country [136] 0 0
Ukraine
State/province [136] 0 0
Kryvyi Rih
Country [137] 0 0
Ukraine
State/province [137] 0 0
Kyiv
Country [138] 0 0
Ukraine
State/province [138] 0 0
Lvov
Country [139] 0 0
Ukraine
State/province [139] 0 0
Odessa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare E7389 versus capecitabine in patients with locally
advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This
is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive
either E7389 or capecitabine on a one-to-one ratio.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00337103
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00337103