Main

Inclusion Criteria:

- Treatment-naive patients with stage II or III invasive breast cancer (proven
histologically/cytologically) and with tests showing an overexpressing of human
epidermal growth factor receptor 2 (HER2).

- Patients have at least one bidimensionally measurable lesion according to the WHO
criteria.

- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0
or 1.

- The patient has an LVEF of at least 55% as assessed by multiple-gated acquisition
(MUGA) scan (preferred) or echocardiography.

- The patient has hematology and serum chemistry laboratory test results within
specific protocol-defined ranges.

- Women of childbearing potential must use a medically accepted method of contraception
and must agree to continue use of this method for the duration of the treatment
period and for 6 months after the last administration of study drug.

Main Exclusion Criteria:

The patient:

- Has received previous cancer therapy for breast cancer.

- Has any history of CHF, angina pectoris, or myocardial infarction.

- Has uncontrolled hypertension.

- Has infection, peptic ulcer, or unstable diabetes mellitus.

- Has been treated with live virus vaccines within 8 weeks before the first
administration of study drug.

- Has impaired hepatic or renal function.

- Is a pregnant or lactating woman. (Any women becoming pregnant during the study will
be withdrawn from the study.)

- Has used an investigational drug within one month before the screening visit.

- Has a known hypersensitivity to any of the study drugs or to their active
ingredients.

- Has an inflammatory breast cancer.

- Has had any other malignancies within five years (except for adequately treated
carcinoma in situ of the cervix or basal or squamous cell skin cancer).