Inclusion Criteria

Inclusion criteria:

1. Female patients >=18 years with proven diagnosis of HER2-overexpressing,
histologically confirmed breast cancer

2. Stage IV metastatic disease

3. At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria
for Solid Tumours version 1.1). Skin, bone and brain lesions are considered
non-target lesions

4. Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and
lapatinib treatment in the neoadjuvant and/or adjuvant setting

Exclusion criteria:

1. Prior first line therapy for metastatic breast cancer

2. Known pre-existing interstitial lung disease

3. Active brain metastases

4. History or presence of clinically relevant cardiovascular abnormalities such as
uncontrolled hypertension, congestive heart failure NYHA classification of 3,
unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6
months prior to trial treatment.

5. Cardiac left ventricular function with resting ejection fraction of less than 50%.

6. Prior treatment with EGFR/HER2-targeted small molecules or antibodies other than
trastuzumab and lapatinib in the neoadjuvant or adjuvant setting

7. Prior treatment with paclitaxel in the past 12 months

8. Must not have received prior vinorelbine treatment

9. Inadequate hepatic, renal and haematologique organ function