This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's satisfaction and safety with subcutaneously administered trastuzumab in participants with HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg) administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs. The trastuzumab regimen could include mono- and/or combination therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Trastuzumab will be administered subcutaneously at a fixed dose of 600 mg (irrespective of body weight) every 3 weeks for 1 year (adjuvant or neo-adjuvant plus adjuvant therapy).
Doxorubicin will be administered in combination with trastuzumab and cyclophosphamide in the adjuvant setting as per local Product Information and the investigator's discretion.
Cyclophosphamide will be administered in combination with trastuzumab and doxorubicin in the adjuvant setting as per local Product Information and the investigator's discretion.
Paclitaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
Docetaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
Carboplatin will be administered in combination with trastuzumab and docetaxel in the adjuvant setting as per local Product Information and the investigator's discretion.
Neo-adjuvant chemotherapy will be administered according to local guidelines in combination with trastuzumab in the neo-adjuvant setting. The study protocol does not mention any specific neo-adjuvant chemotherapy drug names.
Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale
Algiers, Algeria
Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale
Algiers, Algeria
CHU Annaba; Service d'Oncologie Médicale
Annaba, Algeria
EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale
Oran, Algeria
Clinique Littoral
Casablanca, Morocco
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
Marrakesh, Morocco
Institut National D'oncologie Sidi Med Benabdellah
Rabat, Morocco
International Medical Center (IMC)
Jeddah, Saudi Arabia
King Khaled Uni Hospital; Oncology
Riyadh, Saudi Arabia
Abderrahmen Mami Hospital; Medical Oncology department
Aryanah, Tunisia
...and 13 more locations
Participant Satisfaction Questionnaire Score
Time frame: Week 52
Percentage of Participants with Adverse Events (AEs)
Time frame: Baseline up to 4.5 years
Healthcare Professional Experience and Satisfaction Questionnaire Score
Time frame: Week 52
Overall Survival (OS)
Time frame: Baseline until death from any cause (up to 4.5 years)
Disease-Free Survival (DFS)
Diagnosis of breast cancer relapse will be made based on routine clinical, radiological and laboratory criteria. Acceptable methods of confirmation of recurrence include radiology, computed tomography (CT) scan, brain scan, ultrasound, or cytology, as per local practice. In case of uncertainty, disease relapse should be confirmed by histological or cytological examination of a suspicious lesion, if possible.
Time frame: Baseline until first documented disease or death, whichever comes first (up to 4.5 years)
Number of Days on Trastuzumab Treatment
Time frame: Baseline up to 1 year
Total Daily Dose of Trastuzumab
Time frame: Baseline up to 1 year
Cumulative Dose of Trastuzumab
Time frame: Baseline up to 1 year
Duration of Treatment, Follow-up, and Safety Observation
Time frame: Baseline up to 4.5 years
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