['metastatic breast cancer']
['aslan001', 'lapatinib', 'capecitabine']

        Inclusion Criteria:

          -  Patients with documented histological confirmation of breast cancer with HER 2
             overexpression or gene amplification prior to study entry.

          -  Patients with HER 2-positive metastatic breast cancer that have failed on prior first
             line treatment with trastuzumab or who have progressed within 1 year of treatment with
             trastuzumab in adjuvant setting.

          -  Presence of at least one radiographically measurable disease (bone metastases and
             ascites are not considered measurable lesions).

          -  Patients of the respective country's legal age or older at the time of written
             informed consent.

          -  Patients with acceptable organ and hematological function

        Exclusion Criteria:

          -  Patients with radiation treatment or major surgical procedures within 21 days prior to
             study entry.

          -  Patients with malabsorption syndrome, diseases significantly affecting
             gastrointestinal function, resection of the stomach or small bowel, or difficulty in
             swallowing and retaining oral medications.

          -  Patients with an uncontrolled intercurrent illness including, but not limited to,
             ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, diabetes,
             hypertension, or psychiatric illness/social situations that would limit compliance
             with study requirements.

          -  Patients with any history of other malignancy unless in remission for more than 1
             year. (Nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with
             curative intent is not exclusionary).

          -  Patients with symptomatic central nervous system metastasis and/or on systemic
             steroids or anticonvulsants within 3 months before the first dose of randomized
             therapy.

          -  Patients who are pregnant or breast-feeding.

          -  Patients who were previously treated with ASLAN001 and/or with lapatinib.

          -  Patients who have received more than 2 lines of any therapies in metastatic stage.

          -  Patients who have received any investigational drug (or have used an investigational
             device) within 21 days or received any antineoplastic monoclonal antibodies within a
             period of 5 half-lives before receiving the first dose of randomized therapy.

          -  Patients with unresolved or unstable serious toxicity from prior administration of
             another investigational drug and/or prior cancer treatment.
      