Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer

Condition(s) targeted: Adenocarcinoma

Intervention: Epirubicin with Cyclophosphamide, followed by a Taxane (Drug); Epirubicin with a Taxane (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Disease free survival at 3 years

Secondary outcome:

Assess safety in both treatment arms at 3 years

Compare overall survival between the 2 treatment arms at 3 years

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Pfizer Investigational Site, Mobile, Alabama 36608, United States

Pfizer Investigational Site, Tucson, Arizona 85712, United States

Pfizer Investigational Site, Fountain Valley, California 92708, United States

Pfizer Investigational Site, Berkeley, California 94704, United States

Pfizer Investigational Site, Bakersfield, California 93309, 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, Fountian Valley, California 92708, United States

Pfizer Investigational Site, Colorado Springs, Colorado 80907, United States

Pfizer Investigational Site, Jacksonville, Florida 32224, United States

Pfizer Investigational Site, Miami, Florida 33176, United States

Pfizer Investigational Site, Port St. Lucie, Florida 34952, United States

Pfizer Investigational Site, Miami Shores, Florida 33138, United States

Pfizer Investigational Site, Lake Worth, Florida 33461, United States

Pfizer Investigational Site, Jacksonville, Florida, United States

Pfizer Investigational Site, Lecanto, Florida 34461, United States

Pfizer Investigational Site, Tampa, Florida 33607, United States

Pfizer Investigational Site, Kissimmee, Florida 34741, United States

Pfizer Investigational Site, Macon, Georgia 31201, United States

Pfizer Investigational Site, Atlanta, Georgia 30309, 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, Mt. 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, Great Neck, New York 11021`, United States

Pfizer Investigational Site, Brooklyn, New York 11235, United States

Pfizer Investigational Site, Staten Island, New York 10310, United States

Pfizer Investigational Site, Raleigh, North Carolina 27607, United States

Pfizer Investigational Site, Greenville, North Carolina 27854, United States

Pfizer Investigational Site, Burlington, North Carolina 27216, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73104, United States

Pfizer Investigational Site, Lawton, Oklahoma 73505, United States

Pfizer Investigational Site, Lemoyne, Pennsylvania 17043, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19106, United States

Pfizer Investigational Site, Columbia, South Carolina 29201, United States

Pfizer Investigational Site, Charleston, South Carolina, United States

Pfizer Investigational Site, Germantown, Tennessee 38138, United States

Pfizer Investigational Site, Knoxville, Tennessee 37923, United States

Pfizer Investigational Site, Tyler, Texas 11937, United States

Pfizer Investigational Site, Corpus Christi, Texas 78412, United States

Pfizer Investigational Site, Portsmouth, Virginia 23704, United States

Pfizer Investigational Site, Richmond, Virginia 23226, United States

Pfizer Investigational Site, Arlington, Virginia 22205, United States

Pfizer Investigational Site, Milwaukee, Wisconsin 53209, United States

To obtain contact information for a study center near you, click here.

Starting date: November 2000
Ending date: December 2008
Last updated: March 17, 2008