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| ID | Type | Description | Link |
|---|---|---|---|
| GIA 11180 | |||
| H2369n |
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| Name | Class |
|---|---|
| Aventis Pharmaceuticals | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
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In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is well tolerated with minimal myelosuppression, so that it is likely that fully efficacious doses of all three drugs can be administered
Upon determination of eligibility, all patients will be receive:
Trastuzumab + Vinorelbine + Docetaxel
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ||
| Vinorelbine | Drug | Vinorelbine | ||
| Trastuzumab | Drug | Trastuzumab |
| Measure | Description | Time Frame |
|---|---|---|
| feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2. | 18 Months |
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Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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| Name | Affiliation | Role |
|---|---|---|
| John D. Hainsworth, MD | SCRI Development Innovations, LLC | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19299236 | Result | Infante JR, Yardley DA, Burris HA 3rd, Greco FA, Farley CP, Webb C, Spigel DR, Hainsworth JD. Phase II trial of weekly docetaxel, vinorelbine, and trastuzumab in the first-line treatment of patients with HER2-positive metastatic breast cancer. Clin Breast Cancer. 2009 Feb;9(1):23-8. doi: 10.3816/CBC.2009.n.004. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000077235 | Vinorelbine |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| 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 |