This multicenter study in participants with HER2-positive eBC will investigate participants' pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use injection device (SID) or via vial for manual administration using a hand-held syringe (SC vial). In total, participants will obtain at least 18 cycles/1 year of trastuzumab (4 cycles of intravenous \[IV\] and 14 cycles of SC trastuzumab).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Trastuzumab IV or SC will be administered as described.
Paclitaxel will be administered in accordance with local hospital practice.
Docetaxel will be administered in accordance with local hospital practice.
State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology
A/g Lesnoy, Minsk Region, Belarus
Healthcare Institution "Brest Regional Oncologic Dispensary"
Brest, Belarus
Minsk City Clinical Oncologic Dispensary
Minsk, Belarus
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, Belarus
Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department
Almaty, Kazakhstan
Almaty Cancer Hospital; Chemotherapy department
Almaty, Kazakhstan
Oncology centre of Astana; Chemotherapy department
Astana, Kazakhstan
Participant Pain as Measured on a 10 Centimeter (cm) Visual Analogue Scale
Time frame: Week 13 up to Week 52
Participant Discomfort as Measured on a 10 cm Visual Analogue Scale
Time frame: Week 13 up to Week 52
Healthcare Professional Satisfaction With SC Formulation as Assessed by Health Care Professional Questionnaire (HCPQ)
Time frame: Week 22
Patient Satisfaction With SC Formulation as Assessed by Patients Satisfaction Questionnaire (PSQ)
Time frame: Week 52
Healthcare Professional Perceived Time Savings With SC Trastuzumab as Assessed by HCPQ
Time frame: Week 22
Percentage of Participants With Adverse Events
Time frame: Baseline up to approximately 3 years
Overall Survival
Time frame: From first study treatment to death from any cause, assessed up to approximately 4.5 years
Disease-Free Survival, Assessed as per Institutional Practice or American Society of Clinical Oncology (ASCO) Adjuvant Follow-up Guidelines 2006
Time frame: From first study treatment to documented disease progression or death, assessed up to approximately 3 years
Number of Days on Trastuzumab Treatment
Time frame: Week 1 up to Week 52
Total Daily Dose of Trastuzumab
Time frame: Week 1 up to Week 52
Cumulative Dose of Trastuzumab
Time frame: Week 1 up to Week 52
Duration of Treatment
Time frame: Week 1 up to Week 52
Duration of Safety Observation
Time frame: 28 days after last study treatment (up to Week 56)
Duration of Follow-Up
Time frame: 25 months after last study treatment (up to 3 years)
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