Inclusion Criteria include the following :
Signed written informed consent approved by the reviewing
independent Ethics Committee
Female or male aged 18 years or above
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Exclusion Criteria include the following:
Cancer Related Criteria
Previous neoadjuvant or adjuvant breast cancer treatment with an
approved or investigational anti-HER2 agent
History of other malignancy which could affect compliance with the
protocol or interpretation of results. Patients with curatively treated
carcinoma in situ of the cervix or basal cell carcinoma, and patients with
other curatively-treated malignancies who have been disease-free for at
least 5 years, are eligible.
Past history of ductal carcinoma in situ (DCIS) and/or lobular carcinoma
in situ (LCIS) that has been treated with any systemic therapy OR with
radiation therapy to the ipsilateral breast where invasive cancer
subsequently develops. Patients who had their DCIS/LCIS treated with
surgery only are allowed to enter the study.