This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), following surgery and chemotherapy (neo-adjuvant or adjuvant).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
128
600 mg SC Q3W by SID
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Meander Medisch Centrum; Locatie Lichtenberg
Amersfoort, Netherlands
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: From Baseline up to approximately 4 years
Pharmacokinetics: Trough Concentrations (Ctrough) of Trastuzumab
Time frame: Pre-dose (within 1 day before trastuzumab administration) at Cycles 2, 3, 9, and 10, 12 or 13 (cycle length=21 days)
Health Survey Short Form-36 (SF-36) Score
Time frame: Cycles 3 and 9 (cycle length=21 days)
Mood and Anxiety Questionnaire (MASQ) Score
Time frame: Cycles 3 and 9 (cycle length=21 days)
Percentage of Participants Choosing to Return to Hospital Administration
Time frame: Cycle 6 (cycle length=21 days)
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