Clinical trial NCT00165880 (phase 2, status: terminated)
Conditions: metastatic breast cancer
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
Reason stopped: 
    this study was stopped prematurely due to lack of efficacy.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Ambulant female patients with metastatic breast cancer who have been treated
             previously with an anthracycline and a taxane will be enrolled.

          -  Patients must fulfill the following criteria to be included in the study:

          -  Histologically or cytologically confirmed breast cancer with at least one ---
             metastatic uni-dimensionally measurable lesion according to RECIST criteria (the
             following do not qualify as measurable lesions: bone, leptomeningeal disease, ascites,
             pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are
             not confirmed and followed by imaging techniques, and cystic lesions).

          -  Prior treatment with an anthracycline and a taxane.

          -  All previous treatment (including surgery and radiotherapy) must have been completed
             at least 4 weeks prior to study entry and any acute toxicities must have resolved.

          -  Age >= 18 years.

          -  Karnofsky performance status of >= 70%.

          -  Written informed consent to participate in the study.

        Exclusion Criteria:

        Patients with the following characteristics will not be included in the study:

          -  Previously received greater than two prior chemotherapy regimens for metastatic breast
             cancer.

          -  Previously received greater than three prior chemotherapy regimens in total (including
             neo-adjuvant and adjuvant regimens) for breast cancer.

          -  Primary diagnosis of inflammatory breast cancer, confirmed by histology or cytology.

          -  Untreated brain metastases (patients who have been treated for CNS metastases must be
             asymptomatic and radiologically stable for 3 months prior to entry). Patients must not
             have clinical symptoms from brain metastases and must not be taking corticosteroids
             for the treatment of brain metastases. Patients must not have leptomeningeal
             metastases.

          -  Concurrent or previous malignancy of a different tumor type within five years of
             starting the study except for adequately treated non-melanoma skin cancer or cervical
             intraepithelial neoplasia.

          -  Any of the following laboratory parameters:

               1. hemoglobin <10 g/dl;

               2. neutrophils <1.5 x 109/L;

               3. platelets <100 x 109/L;

               4. serum bilirubin >25 µmol/l (1.5 mg/dl);

               5. other liver parameters >2.5 x upper normal limit (ULN) (> 5 x upper normal limit
                  in the presence of hepatic metastases);

               6. serum creatinine >1.5 x ULN;

               7. serum calcium (corrected for albumin) >=11.5 mg/dl.

          -  Uncontrolled infections.

          -  Clinically significant cardiac impairment or unstable ischemic heart disease including
             a myocardial infarction within six months of study start.

          -  Malabsorption syndrome or other condition which may affect drug absorption.

          -  History of hypersensitivity to sulfonamides.

          -  Prior severe or unexpected reaction to fluoropyrimidine therapy (which may be
             explained by dihydropyrimidine dehydrogenase deficiency or hypersensitivity to
             5-fluorouracil).

          -  Any treatment with investigational drugs within 30 days before the start of the study.

          -  Pregnancy or lactation (all women of childbearing potential must have a negative
             pregnancy test before inclusion in the study; post-menopausal women must be
             amenorrheic for at least 12 months). Fertile patients must use adequate contraceptive
             protection.

          -  History of alcoholism, drug addiction, or any psychiatric or psychological condition
             which, in the opinion of the investigator, would impair study compliance.