Inclusion Criteria:

Healthy volunteers (Part 1 only)

• males, 18-45 years of age;
• no history of hypersensitivity or allergic reaction, spontaneous or following drug administration;
• no history of cardiac conditions. Patients (Part 1 and 2)
• females, >=18 years of age;
• ECOG performance status of 0;
• previous non-metastatic operable primary invasive HER2 positive breast cancer;
• baseline LVEF >55%.

Exclusion Criteria:

Healthy volunteers (Part 1 only)

• clinically significant abnormalities in laboratory test results or ECGs;
• LVEF<60%;
• history of significant allergies, gastrointestinal, renal, hepatic, cardiovascular or pulmonary disease.

patients (Parts 1 and 2)

• metastatic disease;
• concurrent other malignancy requiring therapy of any modality which may interfere with PK investigations or result in unexpected toxicity;
• use of herception in previous 5 months;
• serious cardiac illness.