Adenocarcinoma Clinical Trial
Official title:
Phase III, Randomized Study Of Epirubicin/Cyclophosphamide Followed By Taxane (Sequential Chemotherapy) Versus Epirubicin/Taxane (Concurrent Chemotherapy) As Adjuvant Treatment For Operable, Node-Positive Breast Cancer
| Verified date | May 2011 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 606 |
| Est. completion date | August 2006 |
| Est. primary completion date | August 2006 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Breast Cancer Stage T1-3, N1, M0 - Suitable candidate for anthracycline-containing adjuvant chemotherapy Exclusion Criteria: - Evidence of residual tumor following surgery, or metastatic disease - Received prior therapy for breast cancer |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Albuquerque | New Mexico |
| United States | Pfizer Investigational Site | Arlington | Virginia |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Bakersfield | California |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baton Rouge | Louisiana |
| United States | Pfizer Investigational Site | Belleville | Illinois |
| United States | Pfizer Investigational Site | Berkeley | California |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Brooklyn | New York |
| United States | Pfizer Investigational Site | Burlington | North Carolina |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Colorado Springs | Colorado |
| United States | Pfizer Investigational Site | Columbia | South Carolina |
| United States | Pfizer Investigational Site | Corpus Christi | Texas |
| United States | Pfizer Investigational Site | Fountain Valley | California |
| United States | Pfizer Investigational Site | Fountian Valley | California |
| United States | Pfizer Investigational Site | Germantown | Tennessee |
| United States | Pfizer Investigational Site | Gilroy | California |
| United States | Pfizer Investigational Site | Great Neck | New York |
| United States | Pfizer Investigational Site | Greenville | North Carolina |
| United States | Pfizer Investigational Site | Harper Woods | Michigan |
| United States | Pfizer Investigational Site | Hattiesburg | Mississippi |
| United States | Pfizer Investigational Site | Jackson | Mississippi |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Kissimmee | Florida |
| United States | Pfizer Investigational Site | Knoxville | Tennessee |
| United States | Pfizer Investigational Site | Lake Worth | Florida |
| United States | Pfizer Investigational Site | Lawton | Oklahoma |
| United States | Pfizer Investigational Site | Lecanto | Florida |
| United States | Pfizer Investigational Site | Lemoyne | Pennsylvania |
| United States | Pfizer Investigational Site | Macon | Georgia |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Miami Shores | Florida |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Mobile | Alabama |
| United States | Pfizer Investigational Site | Mt. Holly | New Jersey |
| United States | Pfizer Investigational Site | New Orleans | Louisiana |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Port St. Lucie | Florida |
| United States | Pfizer Investigational Site | Portsmouth | Virginia |
| United States | Pfizer Investigational Site | Poway | California |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Skokie | Illinois |
| United States | Pfizer Investigational Site | Soquel | California |
| United States | Pfizer Investigational Site | Staten Island | New York |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Tyler | Texas |
| United States | Pfizer Investigational Site | Willingboro | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease free survival at 3 years | 3 years | No | |
| Secondary | Assess safety in both treatment arms at 3 years | 3 years | No | |
| Secondary | Compare overall survival between the 2 treatment arms at 3 years | 3 years | No |
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