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

May 24, 2011 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

606

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Pfizer Investigational Site
    • California
      • Bakersfield, California, United States, 93309
        • Pfizer Investigational Site
      • Berkeley, California, United States, 94704
        • Pfizer Investigational Site
      • Fountain Valley, California, United States, 92708
        • Pfizer Investigational Site
      • Fountian Valley, California, United States, 92708
        • Pfizer Investigational Site
      • Gilroy, California, United States, 95020
        • Pfizer Investigational Site
      • Poway, California, United States, 92064
        • Pfizer Investigational Site
      • Soquel, California, United States, 95073
        • Pfizer Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32224
        • Pfizer Investigational Site
      • Kissimmee, Florida, United States, 34741
        • Pfizer Investigational Site
      • Lake Worth, Florida, United States, 33461
        • Pfizer Investigational Site
      • Lecanto, Florida, United States, 34461
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33176
        • Pfizer Investigational Site
      • Miami Shores, Florida, United States, 33138
        • Pfizer Investigational Site
      • Port St. Lucie, Florida, United States, 34952
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33607
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
      • Macon, Georgia, United States, 31201
        • Pfizer Investigational Site
    • Illinois
      • Belleville, Illinois, United States, 62226
        • Pfizer Investigational Site
      • Skokie, Illinois, United States, 60076
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Pfizer Investigational Site
      • Baltimore, Maryland, United States, 21236
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Pfizer Investigational Site
    • Michigan
      • Harper Woods, Michigan, United States
        • Pfizer Investigational Site
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Pfizer Investigational Site
      • Jackson, Mississippi, United States, 39202
        • Pfizer Investigational Site
    • New Jersey
      • Mt. Holly, New Jersey, United States, 08060
        • Pfizer Investigational Site
      • Willingboro, New Jersey, United States, 08046
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Pfizer Investigational Site
      • Great Neck, New York, United States, 11021'
        • Pfizer Investigational Site
      • Staten Island, New York, United States, 10310
        • Pfizer Investigational Site
    • North Carolina
      • Burlington, North Carolina, United States, 27216
        • Pfizer Investigational Site
      • Greenville, North Carolina, United States, 27854
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27607
        • Pfizer Investigational Site
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73104
        • Pfizer Investigational Site
    • Pennsylvania
      • Lemoyne, Pennsylvania, United States, 17043
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19106
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Pfizer Investigational Site
      • Columbia, South Carolina, United States, 29201
        • Pfizer Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States, 37923
        • Pfizer Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78412
        • Pfizer Investigational Site
      • Tyler, Texas, United States, 11937
        • Pfizer Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Pfizer Investigational Site
      • Portsmouth, Virginia, United States, 23704
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23226
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B

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

Other Names:
  • Epirubicin, ellence,
Experimental: A

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

Other Names:
  • Epirubicin, ellence,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival at 3 years
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess safety in both treatment arms at 3 years
Time Frame: 3 years
3 years
Compare overall survival between the 2 treatment arms at 3 years
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

May 26, 2011

Last Update Submitted That Met QC Criteria

May 24, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 378-ONC-0030-184

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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