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)

• Disease-free survival [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]
• Overall survival [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]
• Patient satisfaction with trastuzumab SC using the single-use injection device (SID): SID satisfaction questionnaire (patients in cohort B who went on to self-administration of the study drug) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

• Disease-free survival (recurrence assessed according to ASCO 2006 Guideline for Breast Cancer Follow-up) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
• Overall survival [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
• Patient satisfaction with trastuzumab SC single use injection device (SID): SID Satisfaction Questionnaire (cohort B only) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted- and self-administered subcutaneous Herceptin (trastuzumab) as adjuvant therapy in patients with early HER2-positive breast cancer whose tumour has been excised. Patients will receive Herceptin 600 mg subcutaneously every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle (vial formulation, Cohort A) or with assisted- and self-administration using a single-use injection device (SID) in selected patients (Cohort B). Anticipated time on study treatment is up to 1 year.

• Drug: trastuzumab [Herceptin]
  600 mg sc by assisted administration using the vial formulation, into thigh, on Day 1 of each 3-week cycle, 18 cycles
• Drug: trastuzumab [Herceptin]
  600 mg sc by single-use injection device (SID) and by self-administration in select patients, into thigh, on Day 1 of each 3-week cycle, 18 cycles

• Experimental: Cohort A: vial formulation
  Intervention: Drug: trastuzumab [Herceptin]
• Experimental: Cohort B: SID
  Intervention: Drug: trastuzumab [Herceptin]

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