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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00140075
Collaborator
(none)
606
Enrollment
54
Locations
2
Arms
69
Duration (Months)
11.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Epirubicin with Cyclophosphamide, followed by a Taxane
  • Drug: Epirubicin with a Taxane
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
606 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2000
Actual Primary Completion Date :
Aug 1, 2006
Actual Study Completion Date :
Aug 1, 2006

Arms and Interventions

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,

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease free survival at 3 years [3 years]

    Secondary Outcome Measures

    1. Assess safety in both treatment arms at 3 years [3 years]

    2. Compare overall survival between the 2 treatment arms at 3 years [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Mobile Alabama United States 36608
    2 Pfizer Investigational Site Tucson Arizona United States 85712
    3 Pfizer Investigational Site Bakersfield California United States 93309
    4 Pfizer Investigational Site Berkeley California United States 94704
    5 Pfizer Investigational Site Fountain Valley California United States 92708
    6 Pfizer Investigational Site Fountian Valley California United States 92708
    7 Pfizer Investigational Site Gilroy California United States 95020
    8 Pfizer Investigational Site Poway California United States 92064
    9 Pfizer Investigational Site Soquel California United States 95073
    10 Pfizer Investigational Site Colorado Springs Colorado United States 80907
    11 Pfizer Investigational Site Jacksonville Florida United States 32224
    12 Pfizer Investigational Site Jacksonville Florida United States
    13 Pfizer Investigational Site Kissimmee Florida United States 34741
    14 Pfizer Investigational Site Lake Worth Florida United States 33461
    15 Pfizer Investigational Site Lecanto Florida United States 34461
    16 Pfizer Investigational Site Miami Shores Florida United States 33138
    17 Pfizer Investigational Site Miami Florida United States 33176
    18 Pfizer Investigational Site Port St. Lucie Florida United States 34952
    19 Pfizer Investigational Site Tampa Florida United States 33607
    20 Pfizer Investigational Site Atlanta Georgia United States 30309
    21 Pfizer Investigational Site Macon Georgia United States 31201
    22 Pfizer Investigational Site Belleville Illinois United States 62226
    23 Pfizer Investigational Site Skokie Illinois United States 60076
    24 Pfizer Investigational Site Baton Rouge Louisiana United States 70809
    25 Pfizer Investigational Site New Orleans Louisiana United States
    26 Pfizer Investigational Site Baltimore Maryland United States 21236
    27 Pfizer Investigational Site Baltimore Maryland United States 21237
    28 Pfizer Investigational Site Boston Massachusetts United States 02120
    29 Pfizer Investigational Site Harper Woods Michigan United States
    30 Pfizer Investigational Site Hattiesburg Mississippi United States 39401
    31 Pfizer Investigational Site Jackson Mississippi United States 39202
    32 Pfizer Investigational Site Mt. Holly New Jersey United States 08060
    33 Pfizer Investigational Site Willingboro New Jersey United States 08046
    34 Pfizer Investigational Site Albuquerque New Mexico United States 87102
    35 Pfizer Investigational Site Brooklyn New York United States 11235
    36 Pfizer Investigational Site Great Neck New York United States 11021'
    37 Pfizer Investigational Site Staten Island New York United States 10310
    38 Pfizer Investigational Site Burlington North Carolina United States 27216
    39 Pfizer Investigational Site Greenville North Carolina United States 27854
    40 Pfizer Investigational Site Raleigh North Carolina United States 27607
    41 Pfizer Investigational Site Lawton Oklahoma United States 73505
    42 Pfizer Investigational Site Oklahoma City Oklahoma United States 73104
    43 Pfizer Investigational Site Lemoyne Pennsylvania United States 17043
    44 Pfizer Investigational Site Philadelphia Pennsylvania United States 19106
    45 Pfizer Investigational Site Charleston South Carolina United States
    46 Pfizer Investigational Site Columbia South Carolina United States 29201
    47 Pfizer Investigational Site Germantown Tennessee United States 38138
    48 Pfizer Investigational Site Knoxville Tennessee United States 37923
    49 Pfizer Investigational Site Corpus Christi Texas United States 78412
    50 Pfizer Investigational Site Tyler Texas United States 11937
    51 Pfizer Investigational Site Arlington Virginia United States 22205
    52 Pfizer Investigational Site Portsmouth Virginia United States 23704
    53 Pfizer Investigational Site Richmond Virginia United States 23226
    54 Pfizer Investigational Site Milwaukee Wisconsin United States 53209

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00140075
    Other Study ID Numbers:
    • 378-ONC-0030-184
    First Posted:
    Aug 31, 2005
    Last Update Posted:
    May 26, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Adenocarcinoma
    Cyclophosphamide
    Epirubicin
    Taxane

    Study Results

    No Results Posted as of May 26, 2011