Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer

Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Trastuzumab, in Neoadjuvant Setting in Treatment-Naive Patients With HER2-Positive Breast Cancer

To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.

Main Inclusion Criteria:

• Treatment-naive participants with stage II or III invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of HER2.
• Participants have at least 1 bidimensionally measurable lesion according to the World Health Organization (WHO) criteria.
• The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• The participant has an LVEF of at least 55% as assessed by multigated acquisition (MUGA) scan (preferred) or echocardiography.
• The participant 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 participant:

• 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 (Any women becoming pregnant during the study will be withdrawn from the study.)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).

Note: Other inclusion and exclusion criteria may apply.