Study of E7389 for Advanced or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Eribulin Mesylate
Intervention description: Eribulin mesylate 1.4 mg/m^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: Female
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Cancer; breast cancer; neoplasm; E7389; Eribulin

Summary:

      The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate
      the safety of patients who continue to receive E7389 after completing the Phase II clinical
      study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed
      breast cancer by intravenously administering E7389.
    

Eligibility criteria:

        Inclusion criteria:

          1. Female patients with histologically or cytologically confirmed breast cancer.

          2. Patients who have received prior chemotherapy including anthracycline and taxane.

          3. Patients aged 20 - 74 years when giving informed consent and who have given written
             voluntary consent for participating in this study before the completion of Study 221.

          4. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of
             0 to 2.

          5. Patients with a measurable lesion.

          6. Patients with an expected survival of ≥ 3 months from the start of study drug therapy.

          7. Female patients in whom continued administration of E7389 following Study 221 will be
             useful.

          8. Patients who have met the criteria for starting the next cycle in Study 221.

        Namely, patients who meet all of the following criteria:

          1. Neutrophil count >= 1,500 /µL

          2. Platelet count >= 100,000 /µL

          3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the
             upper limit of normal (ULN) in the facility or <= 5 times ULN in patients with hepatic
             metastasis)

          4. Total bilirubin <= 1.5 times ULN

          5. Serum creatinine <= 1.5 times ULN

          6. Non-hematological toxicity <= Grade 2 (excluding disease-associated events and
             laboratory abnormalities without clinical symptoms)

        Exclusion criteria:

          1. Patients with systemic infection with a fever (≥38.0°C).

          2. Patients with pleural effusion, ascites or pericardial fluid requiring drainage.

          3. Patients with brain metastasis presenting clinical symptoms.

          4. Pregnant women, nursing mothers, or premenopausal women of childbearing potential.
             Premenopausal women of childbearing potential are defined as women who are <12 months
             after the latest menstruation and are positive in pregnancy test performed for
             enrollment or who have not taken the test and do not consent to take an appropriate
             contraceptive measure. Post-menopausal women must be amenorrheic for at least 12
             months to make sure that they have no potential for becoming pregnant.

          5. Patients with serious complications:

               1. Patients with uncontrollable cardiac disease such as ischemic heart disease and
                  arrhythmia at a level of severity that needs to be treated (excluding left
                  ventricular hypertrophy, mild left ventricular volume overload and mild right leg
                  block that accompany hypertension)

               2. Patients with myocardial infarction within 6 months prior to study entry

               3. Patients with a complication of hepatic cirrhosis

               4. Patients with interstitial pneumonia and pulmonary fibrosis

               5. Patients with a bleeding tendency

          6. Patients with an active double cancer.

          7. Pregnant women or nursing mothers.

          8. Patients who have received extensive radiotherapy (≥30% of bone marrow).

          9. Patients who refuse to receive the supportive therapy of blood transfusion for
             myelosuppression.

         10. Patients who are participating in other clinical studies.

         11. Patients who are judged by the principal investigator or the other investigators to be
             inappropriate as patients in this clinical study.