Inclusion Criteria

Inclusion criteria:

1. Patients aged 18 years and older

2. Patients with cancers overexpressing HER2 by Immunohistochemistry test( IHC) 3+
and/or IHC 2+ with positive gene amplification by FISH (confirmation on archived
tissue needed)

3. Written informed consent that is consistent with ICH-GCP guidelines.

4. Patients must be eligible for treatment with trastuzumab.

5. Patients must have adequate organ function (kidney, liver, bone marrow, cardiac)

6. Eastern Cooperative Oncology Group (ECOG) = 0 or 1.

7. Measurable disease according to RECIST 1.1 (Phase Ib).

Exclusion criteria:

1. Active brain metastases.

2. Prior treatment with erbB family targeting therapies within the past four weeks
before start of therapy or concomitantly with the trial other than trastuzumab and/or
lapatinib.

3. Patients having more than 2 lines of chemotherapy for the treatment of metastatic
breast cancer (Phase Ib).