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The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Experimental | ET (8 cycles) T = docetaxel or paclitaxel |
|
| A | Experimental | EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles T = docetaxel or paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epirubicin with Cyclophosphamide, followed by a Taxane | Drug | Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2 Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival at 3 years | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety in both treatment arms at 3 years | 3 years | |
| Compare overall survival between the 2 treatment arms at 3 years | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Mobile | Alabama | 36608 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| Epirubicin with a Taxane | Drug | Epirubicin = 75 mg/m2 per cycle Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2 |
|
|
| Tucson |
| Arizona |
| 85712 |
| United States |
| Pfizer Investigational Site | Bakersfield | California | 93309 | United States |
| Pfizer Investigational Site | Berkeley | California | 94704 | United States |
| Pfizer Investigational Site | Fountain Valley | California | 92708 | United States |
| Pfizer Investigational Site | Fountian Valley | California | 92708 | United States |
| Pfizer Investigational Site | Gilroy | California | 95020 | United States |
| Pfizer Investigational Site | Poway | California | 92064 | United States |
| Pfizer Investigational Site | Soquel | California | 95073 | United States |
| Pfizer Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32224 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | United States |
| Pfizer Investigational Site | Kissimmee | Florida | 34741 | United States |
| Pfizer Investigational Site | Lake Worth | Florida | 33461 | United States |
| Pfizer Investigational Site | Lecanto | Florida | 34461 | United States |
| Pfizer Investigational Site | Miami | Florida | 33176 | United States |
| Pfizer Investigational Site | Miami Shores | Florida | 33138 | United States |
| Pfizer Investigational Site | Port Saint Lucie | Florida | 34952 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33607 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30309 | United States |
| Pfizer Investigational Site | Macon | Georgia | 31201 | United States |
| Pfizer Investigational Site | Belleville | Illinois | 62226 | United States |
| Pfizer Investigational Site | Skokie | Illinois | 60076 | United States |
| Pfizer Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21236 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21237 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02120 | United States |
| Pfizer Investigational Site | Harper Woods | Michigan | United States |
| Pfizer Investigational Site | Hattiesburg | Mississippi | 39401 | United States |
| Pfizer Investigational Site | Jackson | Mississippi | 39202 | United States |
| Pfizer Investigational Site | Mount Holly | New Jersey | 08060 | United States |
| Pfizer Investigational Site | Willingboro | New Jersey | 08046 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Pfizer Investigational Site | Brooklyn | New York | 11235 | United States |
| Pfizer Investigational Site | Great Neck | New York | 11021' | United States |
| Pfizer Investigational Site | Staten Island | New York | 10310 | United States |
| Pfizer Investigational Site | Burlington | North Carolina | 27216 | United States |
| Pfizer Investigational Site | Greenville | North Carolina | 27854 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27607 | United States |
| Pfizer Investigational Site | Lawton | Oklahoma | 73505 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| Pfizer Investigational Site | Lemoyne | Pennsylvania | 17043 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19106 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29201 | United States |
| Pfizer Investigational Site | Germantown | Tennessee | 38138 | United States |
| Pfizer Investigational Site | Knoxville | Tennessee | 37923 | United States |
| Pfizer Investigational Site | Corpus Christi | Texas | 78412 | United States |
| Pfizer Investigational Site | Tyler | Texas | 11937 | United States |
| Pfizer Investigational Site | Arlington | Virginia | 22205 | United States |
| Pfizer Investigational Site | Portsmouth | Virginia | 23704 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23226 | United States |
| Pfizer Investigational Site | Milwaukee | Wisconsin | 53209 | United States |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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