Study of E7389 for Advanced or Metastatic Breast Cancer

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.