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

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NCT00140075

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Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adenocarcinoma
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Breast Cancer Stage T1-3, N1, M0

- Suitable candidate for anthracycline-containing adjuvant chemotherapy

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence of residual tumor following surgery, or metastatic disease


- Received prior therapy for breast cancer

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AdenocarcinomaAdjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer
NCT00140075
  1. Mobile, Alabama
  2. Tucson, Arizona
  3. Bakersfield, California
  4. Berkeley, California
  5. Fountain Valley, California
  6. Fountian Valley, California
  7. Gilroy, California
  8. Poway, California
  9. Soquel, California
  10. Colorado Springs, Colorado
  11. Jacksonville, Florida
  12. Jacksonville, Florida
  13. Kissimmee, Florida
  14. Lake Worth, Florida
  15. Lecanto, Florida
  16. Miami Shores, Florida
  17. Miami, Florida
  18. Port St. Lucie, Florida
  19. Tampa, Florida
  20. Atlanta, Georgia
  21. Macon, Georgia
  22. Belleville, Illinois
  23. Skokie, Illinois
  24. Baton Rouge, Louisiana
  25. New Orleans, Louisiana
  26. Baltimore, Maryland
  27. Baltimore, Maryland
  28. Boston, Massachusetts
  29. Harper Woods, Michigan
  30. Hattiesburg, Mississippi
  31. Jackson, Mississippi
  32. Mt. Holly, New Jersey
  33. Willingboro, New Jersey
  34. Albuquerque, New Mexico
  35. Brooklyn, New York
  36. Great Neck, New York
  37. Staten Island, New York
  38. Burlington, North Carolina
  39. Greenville, North Carolina
  40. Raleigh, North Carolina
  41. Lawton, Oklahoma
  42. Oklahoma City, Oklahoma
  43. Lemoyne, Pennsylvania
  44. Philadelphia, Pennsylvania
  45. Charleston, South Carolina
  46. Columbia, South Carolina
  47. Germantown, Tennessee
  48. Knoxville, Tennessee
  49. Corpus Christi, Texas
  50. Tyler, Texas
  51. Arlington, Virginia
  52. Portsmouth, Virginia
  53. Richmond, Virginia
  54. Milwaukee, Wisconsin
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenocarcinoma
Intervention  ICMJE
  • 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 Name: Epirubicin, ellence,
  • Drug: Epirubicin with a Taxane

    Epirubicin = 75 mg/m2 per cycle

    Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2

    Other Name: Epirubicin, ellence,
Study Arms  ICMJE
  • Experimental: B

    ET (8 cycles)

    T = docetaxel or paclitaxel

    Intervention: Drug: Epirubicin with a Taxane
  • Experimental: A

    EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles

    T = docetaxel or paclitaxel

    Intervention: Drug: Epirubicin with Cyclophosphamide, followed by a Taxane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2010)		606
Original Enrollment  ICMJE
 (submitted: August 30, 2005)		617
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00140075
Other Study ID Numbers  ICMJE 378-ONC-0030-184
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP