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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00140075 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma |
Drug: Epirubicin with Cyclophosphamide, followed by a Taxane Drug: Epirubicin with a Taxane |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 603 |
| Study Start Date: | November 2000 |
| Estimated Study Completion Date: | December 2008 |
| Arms | Assigned Interventions |
|---|---|
|
B: Experimental
ET (8 cycles) T = docetaxel or paclitaxel |
Drug: Epirubicin with a Taxane
Epirubicin = 75 mg/m2 per cycle Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2 |
|
A: Experimental
EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles T = docetaxel or paclitaxel |
Drug: Epirubicin with Cyclophosphamide, followed by a Taxane
Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2 Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Pfizer Investigational Site | |
| Fountain Valley, California, United States, 92708 | |
| Pfizer Investigational Site | |
| Gilroy, California, United States, 95020 | |
| Pfizer Investigational Site | |
| Bakersfield, California, United States, 93309 | |
| Pfizer Investigational Site | |
| Berkeley, California, United States, 94704 | |
| Pfizer Investigational Site | |
| Poway, California, United States, 92064 | |
| Pfizer Investigational Site | |
| Soquel, California, United States, 95073 | |
| Pfizer Investigational Site | |
| Fountian Valley, California, United States, 92708 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Colorado Springs, Colorado, United States, 80907 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Port St. Lucie, Florida, United States, 34952 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33176 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32224 | |
| Pfizer Investigational Site | |
| Miami Shores, Florida, United States, 33138 | |
| Pfizer Investigational Site | |
| Lake Worth, Florida, United States, 33461 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States | |
| Pfizer Investigational Site | |
| Lecanto, Florida, United States, 34461 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33607 | |
| Pfizer Investigational Site | |
| Kissimmee, Florida, United States, 34741 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Macon, Georgia, United States, 31201 | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Belleville, Illinois, United States, 62226 | |
| Pfizer Investigational Site | |
| Skokie, Illinois, United States, 60076 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Baton Rouge, Louisiana, United States, 70809 | |
| Pfizer Investigational Site | |
| New Orleans, Louisiana, United States | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21236 | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21237 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02120 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Harper Woods, Michigan, United States | |
| United States, Mississippi | |
| Pfizer Investigational Site | |
| Hattiesburg, Mississippi, United States, 39401 | |
| Pfizer Investigational Site | |
| Jackson, Mississippi, United States, 39202 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Mt. Holly, New Jersey, United States, 08060 | |
| Pfizer Investigational Site | |
| Willingboro, New Jersey, United States, 08046 | |
| United States, New Mexico | |
| Pfizer Investigational Site | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Great Neck, New York, United States, 11021` | |
| Pfizer Investigational Site | |
| Brooklyn, New York, United States, 11235 | |
| Pfizer Investigational Site | |
| Staten Island, New York, United States, 10310 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Raleigh, North Carolina, United States, 27607 | |
| Pfizer Investigational Site | |
| Greenville, North Carolina, United States, 27854 | |
| Pfizer Investigational Site | |
| Burlington, North Carolina, United States, 27216 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Pfizer Investigational Site | |
| Lawton, Oklahoma, United States, 73505 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Lemoyne, Pennsylvania, United States, 17043 | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Columbia, South Carolina, United States, 29201 | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Germantown, Tennessee, United States, 38138 | |
| Pfizer Investigational Site | |
| Knoxville, Tennessee, United States, 37923 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Tyler, Texas, United States, 11937 | |
| Pfizer Investigational Site | |
| Corpus Christi, Texas, United States, 78412 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Portsmouth, Virginia, United States, 23704 | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23226 | |
| Pfizer Investigational Site | |
| Arlington, Virginia, United States, 22205 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | 378-ONC-0030-184 |
| Study First Received: | August 29, 2005 |
| Last Updated: | March 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00140075 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Skin Diseases Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Antibiotics, Antineoplastic Epirubicin Immunosuppressive Agents Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Adenocarcinoma Alkylating Agents Taxane Breast Diseases Neoplasms, Glandular and Epithelial |
