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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Randomization (Trastuzumab IV) | Experimental | Trastuzumab IV will be given during the first 4 cycles for all participants before randomization for SC administration. A dose of 6 milligrams per kilogram (mg/kg) will be given every 3 weeks. All the participants will require a loading dose on Day 1 of Cycle 1, so they will receive 8 mg/kg followed by 6 mg/kg, 3 weeks later and then 3-weekly. Concurrent administration during the first 4 cycles of trastuzumab IV with paclitaxel/docetaxel will have to be performed in accordance with local hospital practice. |
|
| Group A: Trastuzumab SC (First Vial Formulation, then SID) | Experimental | Participants will receive 7 cycles of SC trastuzumab 600 mg with assisted administration using a conventional syringe and needle (SC vial formulation) followed by 7 cycles of SC trastuzumab 600 mg SID administration after cross-over. |
|
| Group B: Trastuzumab SC (First SID, then Vial Formulation) | Experimental | Participants will start with 7 cycles of SC trastuzumab 600 mg administration via SID and after cross-over will receive 7 injections of trastuzumab 600 mg with assisted administration using a conventional syringe and needle (SC vial formulation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Trastuzumab IV or SC will be administered as described. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Pain as Measured on a 10 Centimeter (cm) Visual Analogue Scale | Week 13 up to Week 52 | |
| Participant Discomfort as Measured on a 10 cm Visual Analogue Scale | Week 13 up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Professional Satisfaction With SC Formulation as Assessed by Health Care Professional Questionnaire (HCPQ) | Week 22 | |
| Patient Satisfaction With SC Formulation as Assessed by Patients Satisfaction Questionnaire (PSQ) | Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology | A/g Lesnoy, Minsk Region | 223040 | Belarus |
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| Paclitaxel | Drug | Paclitaxel will be administered in accordance with local hospital practice. |
|
| Docetaxel | Drug | Docetaxel will be administered in accordance with local hospital practice. |
|
| Healthcare Professional Perceived Time Savings With SC Trastuzumab as Assessed by HCPQ | Week 22 |
| Percentage of Participants With Adverse Events | Baseline up to approximately 3 years |
| Overall Survival | 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 | From first study treatment to documented disease progression or death, assessed up to approximately 3 years |
| Number of Days on Trastuzumab Treatment | Week 1 up to Week 52 |
| Total Daily Dose of Trastuzumab | Week 1 up to Week 52 |
| Cumulative Dose of Trastuzumab | Week 1 up to Week 52 |
| Duration of Treatment | Week 1 up to Week 52 |
| Duration of Safety Observation | 28 days after last study treatment (up to Week 56) |
| Duration of Follow-Up | 25 months after last study treatment (up to 3 years) |
| Healthcare Institution "Brest Regional Oncologic Dispensary" | Brest | 224027 | Belarus |
| Minsk City Clinical Oncologic Dispensary | Minsk | BU-220013 | Belarus |
| Vitebsk Regional Clinical Oncology Dispensary | Vitebsk | BU-210603 | Belarus |
| Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department | Almaty | 050022 | Kazakhstan |
| Almaty Cancer Hospital; Chemotherapy department | Almaty | 050054 | Kazakhstan |
| Oncology centre of Astana; Chemotherapy department | Astana | 010000 | Kazakhstan |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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