Clinical trial NCT00615940 (phase 2, status: completed)
Conditions: metastatic breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: wx-671, placebo
SMILES: CCOC(=O)N1CCN(CC1)C(=O)[C@H](CC1=CC=CC(=C1)C(\N)=N/O)NS(=O)(=O)C1=C(C=C(C=C1C(C)C)C(C)C)C(C)C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Females aged ≥ 18 years

          -  Patients appropriate for palliative first-line, mono chemotherapy with capecitabine

          -  Histological or cytological confirmed, non-inflammatory metastatic breast cancer

          -  Availability of paraffin-embedded tumor tissue from the primary resection or biopsy of
             a metastatic lesion.

          -  HER2-negative breast cancer

          -  Complete staging within 2 weeks prior to randomization (4 weeks for bone scan).

          -  Radiologically confirmed disease

          -  ECOG performance status of ≤ 2

          -  Ability to understand and willingness to voluntarily sign and date a written informed
             consent form before screening

          -  Negative pregnancy test (urine or serum) within 3 days before first study drug for
             women of childbearing potential. Use of effective contraception during the study and
             for 3 months after stopping study drug treatment.

          -  Normal organ and marrow function as defined by laboratory parameters (obtained within
             the screening period) within the following limits:

               -  neutrophils >= 1.5 x 109/L;

               -  platelets >= 100 x 109/L;

               -  hemoglobin >= 9.0 g/dL (5.6 mmol/L).

               -  total bilirubin <= 1.5 x upper limit of normal (ULN);

               -  aspartate aminotransferase (AST)/ALT <= 2.5 x ULN (< 5.0 x ULN for patients with
                  liver metastases);

               -  serum creatinine <= 2 x ULN, or calculated creatinine clearance >45 mL/min
                  according to Cockroft and Gault formula).

        Exclusion Criteria:

          -  Endocrine therapy completed within 2 weeks before the start of treatment (i.e.
             previous hormone therapy is allowed provided that there is a washout period of 2
             weeks).

          -  Prior chemotherapy or biologic therapy for metastatic disease.

          -  Major surgery within 4 weeks prior to the start of treatment.

          -  Other anti-cancer treatment (e.g. hormones) within 2 weeks before the start of
             treatment.

          -  Treatment within 12 months with adjuvant 5-FU containing chemotherapy (regarded as
             indicating 5-FU resistance) and/or prior capecitabine therapy.

          -  Radiation therapy. Palliative radiation of stable, non-target lesions more than 2
             weeks before the start of treatment is allowed, provided patients have recovered from
             the radiation side-effects.

          -  History of or radiological evidence of brain metastasis including previously treated,
             resected or asymptomatic brain lesions or leptomeningeal involvement.

          -  Active seizure disorder or history of cerebrovascular accident (CVA) or transient
             ischemic (TI) attack within the past 12 months.

          -  History of other malignancy within the last 3 years except for surgically cured
             non-melanoma skin cancer or cervical carcinoma in situ.

          -  Active cardiac disease e.g. unstable angina, congestive heart failure, myocardial
             infarction (MI) within the preceding 6 months.

          -  Any medical condition prohibiting standard imaging procedures

          -  Pregnant or breast-feeding.

          -  Any unrelated illness, e.g. active infection requiring parenteral antibiotics,
             inflammation, medical condition or laboratory abnormalities, which in the judgment of
             the investigator might significantly affect patients' study participation.

          -  Any surgical or medical condition that might significantly alter the absorption,
             distribution, metabolism or excretion of either study drug.

          -  Known hepatitis B/C or HIV (human immunodeficiency virus) infection.