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This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast cancer setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aranesp | Experimental |
| |
| Neulasta | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neulasta | Drug | 6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Febrile neutropenic events and adverse event profile will be assessed | 4 months | |
| To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| Aranesp |
| Drug |
If Hb drops below 110, 300mcg Aranesp will be administered. |
|
| Frequency of red blood cell (RBC) transfusions | 3 months |
| 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 |
|---|---|
| C455861 | pegfilgrastim |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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