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| Name | Class |
|---|---|
| Aventis Pharmaceuticals | INDUSTRY |
The primary objective of this study is to determine the efficacy & toxicity of combined docetaxel & capecitabine as primary chemo for subjects w/ stage II-III breast cancer.
The primary objective of this study is to determine the efficacy & toxicity of combined docetaxel & capecitabine as primary chemotherapy for subjects with stage II-III breast cancer.Subjects will be randomized into one of two groups: Docetaxel followed by four cycles of docetaxel & capecitabine vs. capecitabine followed by four cycles of docetaxel and capecitabine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel & capecitabine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to determine the efficacy & toxicity of combined docetaxel & capecitabine as primary chemotherapy for subjects with stage II-III breast cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate genomic and proteonomic changes after initial therapy with docetaxel & capecitabine as monotherapy after combined docetaxel & capecitabine therapy. | ||
| To compare pre-treatment genomic and proteomic profiles in responders and non-responders. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Miller, M.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
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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 |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| To compare the results of serum-based and tissue-based proteomic analyses. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |