This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.
Study Type
OBSERVATIONAL
Enrollment
510
Safety (composite outcome measure): Incidence, nature, and severity according to NCI-CTCAE v. 4.0 of: adverse events (AEs), serious AEs, grade >/= 3 AEs, non-serious adverse drug reaction or causality unknown, AESI (congestive heart failure)
Time frame: approximately 13 months
Demographic data
Time frame: Up to 12 months
Number of modalities regarding dose and injection site of Herceptin SC administration
Time frame: Up to 12 months
Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire
Time frame: Every 3 months, up to 12 months
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