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E7389 Versus Capecitabine in ...

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

Last Updated: 2020-06-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-20

Study Completion Date

2017-12-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Eribulin Mesylate

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

Capecitabine

Intervention Type DRUG

Capecitabine 2.5 g/m\^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days

Interventions

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Eribulin Mesylate

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

Intervention Type DRUG

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 Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anaheim, California, United States

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La Verne, California, United States

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Poway, California, United States

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Centralia, Illinois, United States

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Augusta, Maine, United States

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Boston, Massachusetts, United States

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Jefferson City, Missouri, United States

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Lebanon, New Hampshire, United States

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Ephrata, Pennsylvania, United States

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Cookeville, Tennessee, United States

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Germantown, Tennessee, United States

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Amarillo, Texas, United States

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Wenatchee, Washington, United States

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Hospital General de Agudos Teodoro Alvarez

Ciudad Autonoma, Buenos Aires, Argentina

Bankstown, New South Wales, Australia

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Burgas, , Bulgaria

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Gabrovo, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Shumen, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Varna, , Bulgaria

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Bochum, , Germany

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Hamburg, , Germany

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Homburg, , Germany

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Universitatsfrauenklinik Magdeburg

Magdeburg, , Germany

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Rostock, , Germany

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Pátrai, , Greece

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Gyor, Budapest, Hungary

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Debrecen University

Debrecen, , Hungary

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Debrecen, , Hungary

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Gyula, , Hungary

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Pecsi Tudomanyegyetem, Onkoterapias Intezet

Pécs, , Hungary

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Szeged, , Hungary

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Unita Operativa de Oncologia

Lugo, , Italy

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Meldola, , Italy

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Modena, , Italy

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Azienda Ospedaliera San Salvatore

Pesaro, , Italy

Morelia, , Mexico

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Regionalny Osrodek Onkologii

Bialystok, , Poland

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Bytom, , Poland

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Elblag, , Poland

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Wojewodzkie Centrum Onkologii

Gdansk, , Poland

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Krakow, , Poland

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Olsztyn, , Poland

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Rybnik, , Poland

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Torun, , Poland

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Wojewodzki Szpital Specjalistyczny

Wroclaw, , Poland

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Cluj-Napoca, Cluj, Romania

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Spitalul Militar Central Bucuresti

Bucharest, , Romania

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Obninsk, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Sochi, , Russia

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Tomsk, , Russia

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Vladimir, , Russia

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Singapore, , Singapore

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Mayville, Durban, South Africa

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Pretoria, Gaunteng, South Africa

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Groenkloof, Pretoria, South Africa

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Panorama Medical Centre

Cape Town, , South Africa

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Durban, , South Africa

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Johannesburg, , South Africa

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Sandton, , South Africa

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Barakaldo, Vizcaya, Spain

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A Coruña, , Spain

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Barcelona, , Spain

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Guadalajara, , Spain

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Seville, , Spain

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Valencia, , Spain

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Changhua, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Yung-Kang City, , Taiwan

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Chernihiv, , Ukraine

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Dnipro, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Khmelnytskyi, , Ukraine

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Kiev, , Ukraine

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Kryvyi Rih, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Countries

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United States Argentina Australia Belgium Brazil Bulgaria Canada Czechia France Germany Greece Hungary Israel Italy Mexico Poland Romania Russia Singapore South Africa Spain Taiwan Ukraine