Clinical trial NCT00080197 (phase 2, status: completed)
Conditions: breast neoplasms, metastases
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: e7070
SMILES: NS(=O)(=O)C1=CC=C(C=C1)S(=O)(=O)NC1=CC=CC2=C1NC=C2Cl
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be female,

          -  Patients must have histologically or cytologically confirmed metastatic breast cancer,

          -  Patients must either have tumors that are resistant/refractory to chemotherapy with an
             anthracycline, a taxane, capecitabine, and appropriate Herceptin therapy, or tumors
             that cannot be treated with these agents due to patient's treatment toxicity;
             therefore, patients must have received 2 prior chemotherapies but no more than 3 prior
             chemotherapies in the metastatic setting,

          -  Patients must have at least one uni-dimensionally measurable lesion according to the
             RECIST criteria in at least one site that has not been irradiated,

          -  Patients must be aged >= 18 years,

          -  Patients must have a Karnofsky Performance Status of >= 70%,

          -  Patients must have a life expectancy of >= 3 months,

          -  Patients must have adequate renal function as evidenced by serum creatinine <= 1.5
             mg/dL, or if > 1.5 but <= 1.8 mg/dL, then a creatinine clearance of >= 45 mL/min,

          -  Patients must have adequate bone marrow function as evidenced by absolute neutrophil
             count of >= 1.5 x 109/L, hemoglobin >= 9.0 g/dL, and platelet count >= 100 x 109/L,

          -  Patients must have adequate liver function as evidenced by bilirubin of <= 1.5 times
             the upper limits of normal (ULN); alkaline phosphatase <= 3 times ULN and alanine
             transaminase (ALT) and aspartate transaminase (AST) <= 3 times ULN, unless related to
             liver metastasis, in which case <= 5 x ULN,

          -  Patients must have serum electrolytes including calcium (corrected for albumin),
             magnesium, and potassium (corrected) within normal limits,

          -  Patients must be willing and able to complete the FACT-B questionnaire,

          -  Patients must be willing and able to comply with the study protocol for the duration
             of the study, and

          -  Patients must give 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:

          -  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.