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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000829-31 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab | Experimental | Participants will receive 600 milligrams (mg) trastuzumab SC by SID every 3 weeks (Q3W) for up to a total of 1 year, unless disease recurrence, unacceptable toxicity or participant withdrawal occurs. The first 3 administrations will be done at hospital, after that participants will be permitted to self-administer under the supervision of a healthcare professional (HCP). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | 600 mg SC Q3W by SID |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | From Baseline up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Trough Concentrations (Ctrough) of Trastuzumab | 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 | Cycles 3 and 9 (cycle length=21 days) |
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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 |
|---|---|---|---|---|---|---|
| Medisch Centrum Alkmaar | Alkmaar | 1815 JD | Netherlands | |||
| Meander Medisch Centrum; Locatie Lichtenberg |
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| Mood and Anxiety Questionnaire (MASQ) Score | Cycles 3 and 9 (cycle length=21 days) |
| Percentage of Participants Choosing to Return to Hospital Administration | Cycle 6 (cycle length=21 days) |
| Amersfoort |
| 3818 ES |
| Netherlands |
| Amphia ziekenhuis, locatie langendijk | Breda | 4819 EV | Netherlands |
| IJsselland Ziekenhuis | Capelle aan den IJssel | 2906 ZC | Netherlands |
| Reinier de Graaf Gasthuis; Oncology | Delft | 2600 GA | Netherlands |
| Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde | Ede | 6716 RP | Netherlands |
| Martini Ziekenhuis | Groningen | 9728 MG | Netherlands |
| Kennemer Gasthuis | Haarlem | 2035 RC | Netherlands |
| Ziekenhuisgroep Twente, Hengelo | Hengelo | 7555 DL | Netherlands |
| Tergooiziekenhuizen, loc. Hilversum | Hilversum | 1213 HX | Netherlands |
| Spaarne Ziekenhuis Haarlem; Oncologie | Hoofddorp | 2134 TM | Netherlands |
| St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | 3430 EM | Netherlands |
| Franciscus Ziekenhuis | Roosendaal | 4708 AE | Netherlands |
| Zuyderland ziekenhuis locatie Geleen | Sittard-Geleen | 6162 BG | Netherlands |
| Haga Ziekenhuis | The Hague | 2504 LN | Netherlands |
| VieCuri - Medisch Centrum voor Noord-Limburg | Venlo | 5912 BL | Netherlands |
| Isala Klinieken | Zwolle | 8011 JW | Netherlands |
| 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 |
| 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 |
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