Study to Evaluate the Efficacy, Safety, and Tolerability of E7070 in Metastatic Breast Cancer Patients

Exclusion Criteria

• •Patients must not have metastatic disease that can be completely surgically resected,
• •Patients who received adjuvant taxane must not have experienced disease progression within 12 months of beginning that therapy,
• •Patients must not have received chemotherapy, hormonal therapy, or Herceptin within 2 weeks of E7070 treatment start and must have recovered from any chemotherapy-related or other therapy-related toxicity at study entry,
• •Patients must not have received investigational drugs including immunotherapy, gene therapy, or other biologic therapy; antineoplastic therapy; or radiation therapy (other than required for palliation of bone pain or chest ulceration) within 2 weeks of E7070 treatment,
• •Patients must not have received prior treatment with Mitomycin C or nitrosoureas,
• •Patients must not have undergone high dose chemotherapy with hematopoietic stem cell rescue,
• •Patients must not have untreated brain metastases (Patients who have been treated for central nervous system (CNS) metastases must be asymptomatic and radiologically stable \[not receiving radiation\] and must not have been receiving steroids for 4 weeks prior to entry.
• •Patients without known CNS metastases who are symptomatic for CNS metastasis must be evaluated with a CT scan or MRI scan prior to E7070 treatment.),
• •Patients must not have had major surgery without full recovery within 4 weeks of E7070 treatment start,
• •Patients must not have pulmonary lymphatic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen,
• •Patients must not have leptomeningeal metastasis,
• •Patients must not have evidence of clinically relevant ascites or pleural effusion requiring more than one isolated paracentesis or pleurocentesis per month prior to study start,
• •Patients must not be expected to require more than one isolated paracentesis or pleurocentesis per month during the study for the treatment of clinically relevant ascites or pleural effusion,
• •Patients must not be pregnant or breast-feeding and must practice adequate contraception if not surgically sterile,
• •Patients must not have severe medically uncontrolled intercurrent illness/infection,
• •Patients must not have had unstable angina or myocardial infarction in the past 6 months,
• •Patients must not have serious cardiac arrhythmia or symptomatic congestive heart failure \>= Grade II (NYHA classification),
• •Patients must not have a history of prolonged QT, QTc \> 470 ms (Bazett's correction) at entry, or history of torsade de pointes,
• •Patients must not have recent history (\<= 12 months) of active or chronic viral hepatitis,
• •Patients must not have organ allografts,
• •Patients must not have known history of HIV positivity,
• •Patients must not have a history of hypersensitivity to sulfonamides,
• •Patients must not have a history of uncontrolled seizures,
• •Patients must not have had a prior malignancy, other than carcinoma in situ of the cervix or nonmelanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated \>= 5 years previously with no subsequent evidence of recurrence, or
• •Patients must not have other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.