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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004591-10 | EudraCT Number |
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This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild hepatic dysfunction | Experimental |
| |
| Moderate hepatic dysfunction | Experimental |
| |
| Normal hepatic function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab emtansine | Drug | Multiple intravenous doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration-time curve | Multiple sampling pre- and up to 21 days post-dose Cycles 1-3 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events in patients with mild or moderate hepatic impairment as compared to patients with normal hepatic function | approximately 2 years |
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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 |
|---|---|---|---|---|---|---|
| Fort Myers | Florida | 33905 | United States | |||
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| Detroit |
| Michigan |
| 48201 |
| United States |
| Portland | Oregon | 97239 | United States |
| Nashville | Tennessee | 37203 | United States |
| Ottawa | Ontario | K1H8L6 | Canada |
| Toronto | Ontario | M5G 2M9 | Canada |
| Marseille | 13273 | France |
| Paris | 75231 | France |
| Toulouse | 31059 | France |
| Catanzaro | Calabria | 88100 | Italy |
| Udine | Friuli Venezia Giulia | 33100 | Italy |
| Barcelona | Barcelona | 08003 | Spain |
| Madrid | Madrid | 28007 | Spain |
| 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 |
|---|---|
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000068878 | Trastuzumab |
| 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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