A Safety and Tolerability Study of Assisted- and Self-Administered Subcutaneous Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With Early HER2-Positive Breast Cancer (SafeHer)

Inclusion Criteria:

• Adult male or female patients, >/= 18 years of age
• Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage I to IIIC that is eligible for adjuvant treatment with trastuzumab
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Screening left ventricular ejection fraction (LVEF) >/= 55%

Exclusion Criteria:

• Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
• History of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years
• Past history of ductal carcinoma in situ that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops
• Metastatic disease
• Inadequate bone marrow, hepatic or renal function
• Serious cardiac or cardiovascular disease
• Uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy
• History of severe allergic or immunological reactions, e.g. difficult to control asthma
• Pregnant or lactating women