Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer

Back to Search
Print
Bookmark Trial

NCT00129922

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Hospital Universitario Virgen de los Lirios
Alcoy, Alicante, 03804, Spain
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Written informed consent.

- Histological diagnosis of breast cancer.

- Node positive operable breast cancer (stages II-III).

- Breast cancer surgery, consisting of radical mastectomy or conservative surgery, plus lymphadenectomy with at least 6 extirpated nodes. Surgery must have happened in the 8 weeks prior to randomisation.

- Age >=18 and <= 70 years old.

- Negative pregnancy test. Adequate contraceptive method during the study participation.

- Performance status of 90-100 (Karnofsky index) or ECOG <=1.

- Haemoglobin >= 10 g/dl; neutrophils > 1,500/cc; platelets > 100,000/cc.

- Adequate hepatic function with bilirubin, SGOT and SGPT < 1.5 x upper normal limit (UNL).

- Adequate cardiac function documented by left ventricular ejection fraction (LVEF).

- Adequate renal function with creatinine < 1.5 mg/dl.

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


- Previous chemotherapy, hormone therapy and/or radiotherapy for breast cancer.


- Bilateral breast cancer. Lobular in situ carcinoma.


- Previous or current malignancies, except for basal skin carcinoma, cervical in situ
carcinoma or superficial bladder carcinoma, adequately treated.


- History of arrhythmias and/or congestive heart failure or cardiac blocking grade 2-3;
history of myocardial infarction in 6 months before recruitment.


- Inability for treatment and study compliance.


- Pregnant or lactating women.


- Active infection.


- History of hypersensitivity to cremophor or cyclosporine.


- Pre-existing grade 2 motor or sensorial neurotoxicity (National Cancer Institute
Common Toxicity Criteria [NCI CTC]).


- Hormonal receptor status not determined.


- Any other criteria which, in investigator's opinion, may jeopardize patient's security
or compliance.


- Administration of other investigational product in the 30 days prior to randomisation;
current participation in another clinical trial.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Breast CancerNeoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 -
NCT03819010
  1. Badalona, Barcelona
  2. Madrid,
  3. Valencia,
  4. Oporto,
Female
18 Years+
years
MULTIPLE SITES
Breast CancerExemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer
NCT00201773
  1. Columbus, Ohio
Female
18 Years+
years
MULTIPLE SITES
Breast CancerPALbociclib CoLlaborative Adjuvant Study
NCT02513394
  1. Mobile, Alabama
  2. Mobile, Alabama
  3. Anchorage, Alaska
  4. Anchorage, Alaska
  5. Phoenix, Arizona
  6. Greenbrae, California
  7. Greenbrae, California
  8. La Jolla, California
  9. Los Angeles, California
  10. Oakland, California
  11. Palo Alto, California
  12. Roseville, California
  13. Sacramento, California
  14. San Diego, California
  15. San Diego, California
  16. San Diego, California
  17. San Francisco, California
  18. San Francisco, California
  19. San Leandro, California
  20. Santa Clara, California
  21. South San Francisco, California
  22. Stanford, California
  23. Vallejo, California
  24. Walnut Creek, California
  25. Denver, Colorado
  26. Hartford, Connecticut
  27. New Britain, Connecticut
  28. Newark, Delaware
  29. Washington, District of Columbia
  30. Washington, District of Columbia
  31. Clearwater, Florida
  32. Jacksonville, Florida
  33. Miami Beach, Florida
  34. Miami, Florida
  35. Orlando, Florida
  36. Atlanta, Georgia
  37. Chicago, Illinois
  38. Chicago, Illinois
  39. Chicago, Illinois
  40. Decatur, Illinois
  41. Harvey, Illinois
  42. Joliet, Illinois
  43. Park Ridge, Illinois
  44. Peoria, Illinois
  45. Rockford, Illinois
  46. Skokie, Illinois
  47. Skokie, Illinois
  48. Urbana, Illinois
  49. Indianapolis, Indiana
  50. Muncie, Indiana
  51. Ames, Iowa
  52. Ames, Iowa
  53. Cedar Rapids, Iowa
  54. Des Moines, Iowa
  55. Waterloo, Iowa
  56. Lexington, Kentucky
  57. Louisville, Kentucky
  58. New Orleans, Louisiana
  59. Bangor, Maine
  60. Scarborough, Maine
  61. Annapolis, Maryland
  62. Baltimore, Maryland
  63. Baltimore, Maryland
  64. Baltimore, Maryland
  65. Baltimore, Maryland
  66. Baltimore, Maryland
  67. Baltimore, Maryland
  68. Bethesda, Maryland
  69. Salisbury, Maryland
  70. Silver Spring, Maryland
  71. Boston, Massachusetts
  72. Boston, Massachusetts
  73. Boston, Massachusetts
  74. Boston, Massachusetts
  75. Lowell, Massachusetts
  76. Plymouth, Massachusetts
  77. Ann Arbor, Michigan
  78. Grand Rapids, Michigan
  79. Livonia, Michigan
  80. Duluth, Minnesota
  81. Rochester, Minnesota
  82. Rochester, Minnesota
  83. Saint Cloud, Minnesota
  84. Saint Louis Park, Minnesota
  85. Saint Louis Park, Minnesota
  86. Kansas City, Missouri
  87. Rolla, Missouri
  88. Saint Louis, Missouri
  89. Saint Louis, Missouri
  90. Saint Louis, Missouri
  91. Springfield, Missouri
  92. Omaha, Nebraska
  93. Concord, New Hampshire
  94. Hooksett, New Hampshire
  95. Lebanon, New Hampshire
  96. Lebanon, New Hampshire
  97. Englewood, New Jersey
  98. Hackensack, New Jersey
  99. Albuquerque, New Mexico
  100. Albuquerque, New Mexico
  101. Bronx, New York
  102. Buffalo, New York
  103. East Syracuse, New York
  104. Jamaica, New York
  105. New Hyde Park, New York
  106. New York, New York
  107. New York, New York
  108. New York, New York
  109. Oneonta, New York
  110. Syracuse, New York
  111. Charlotte, North Carolina
  112. Durham, North Carolina
  113. Greensboro, North Carolina
  114. Pinehurst, North Carolina
  115. Rapid City, North Dakota
  116. Cleveland, Ohio
  117. Cleveland, Ohio
  118. Columbus, Ohio
  119. Mayfield Heights, Ohio
  120. Lawton, Oklahoma
  121. Oklahoma City, Oklahoma
  122. Oklahoma City, Oklahoma
  123. Portland, Oregon
  124. Dunmore, Pennsylvania
  125. Hershey, Pennsylvania
  126. Lancaster, Pennsylvania
  127. Philadelphia, Pennsylvania
  128. Philadelphia, Pennsylvania
  129. Philadelphia, Pennsylvania
  130. Philadelphia, Pennsylvania
  131. Pittsburgh, Pennsylvania
  132. Pittsburgh, Pennsylvania
  133. Wyomissing, Pennsylvania
  134. York, Pennsylvania
  135. Providence, Rhode Island
  136. Providence, Rhode Island
  137. Columbia, South Carolina
  138. Aberdeen, South Dakota
  139. Rapid City, South Dakota
  140. Sioux Falls, South Dakota
  141. Nashville, Tennessee
  142. Nashville, Tennessee
  143. Houston, Texas
  144. Houston, Texas
  145. Houston, Texas
  146. Laredo, Texas
  147. Salt Lake City, Utah
  148. Fairfax, Virginia
  149. Richmond, Virginia
  150. Charleston, West Virginia
  151. Appleton, Wisconsin
  152. Green Bay, Wisconsin
  153. La Crosse, Wisconsin
  154. Madison, Wisconsin
  155. Milwaukee, Wisconsin
  156. Milwaukee, Wisconsin
  157. Racine, Wisconsin
  158. Waukesha, Wisconsin
  159. Waukesha, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Breast CancerExemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
NCT00201864
  1. Columbus, Ohio
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer
Official Title  ICMJE Phase III Study to Compare 6 Courses of FEC (Fluorouracil, Epirubicin and Cyclophosphamide) vs. 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Positive Operable BC Patients
Brief Summary

The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence.

Also, for axillary positive node patients, optimum chemotherapy regimens are still under discussion. Some previous studies suggest that, in the subset of node-positive patients, treatments based on sequential administration of anthracyclines and taxanes are more efficient. Paclitaxel dose-dense (weekly) administration renders an improved therapeutic index (activity/toxicity).

The study is designed to compare 6 courses of FEC scheme (600/90/600), a combination of proven efficacy in node positive breast cancer patients, versus 4 FEC courses followed by 8 weekly paclitaxel administrations (100mg/m2).

The study hypothesis is that 5-year disease-free survival in the control arm will be 60%. The investigators expect to increase this by 8% with the experimental treatment. With an alpha error of 0.05, 80% power, and a post-randomization estimated drop-out rate of 10%, 1250 patients are needed, 625 per arm.

Detailed Description The primary endpoint of study-5-year disease-free survival (DFS) will be assessed by Kaplan Meier analysis. Secondary endpoints included overall survival and analysis of the prognostic and predictive value of clinical and molecular markers. Associations and interactions will be assessed with a multivariable Cox proportional hazards model for DFS for the following covariates: age, menopausal status, tumor size, lymph node status, type of chemotherapy, tumor size, positive lymph nodes, HER2 status, and hormone receptor status. All statistical tests will be two-sided.
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 Breast Cancer
Intervention  ICMJE
  • Drug: paclitaxel
    Other Name: Taxol
  • Drug: Fluorouracil
    Other Name: 5-FU
  • Drug: Epirubicin
    Other Name: 4-Epirubicin
  • Drug: Cyclophosphamide
Study Arms  ICMJE
  • Active Comparator: Fluorouracil+Epirubicin+Cyclophosphamide
    5-FU+4-Epirubicin+Cyclophosphamide
    Interventions:
    • Drug: Fluorouracil
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
  • Experimental: FEC followed by Paclitaxel
    5-FU+4-Epirubicin+Cyclophosphamide
    Interventions:
    • Drug: paclitaxel
    • Drug: Fluorouracil
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
Publications *

*   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: March 15, 2018)		1289
Original Enrollment  ICMJE
 (submitted: August 11, 2005)		1250
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent.
  • Histological diagnosis of breast cancer.
  • Node positive operable breast cancer (stages II-III).
  • Breast cancer surgery, consisting of radical mastectomy or conservative surgery, plus lymphadenectomy with at least 6 extirpated nodes. Surgery must have happened in the 8 weeks prior to randomisation.
  • Age >=18 and <= 70 years old.
  • Negative pregnancy test. Adequate contraceptive method during the study participation.
  • Performance status of 90-100 (Karnofsky index) or ECOG <=1.
  • Haemoglobin >= 10 g/dl; neutrophils > 1,500/cc; platelets > 100,000/cc.
  • Adequate hepatic function with bilirubin, SGOT and SGPT < 1.5 x upper normal limit (UNL).
  • Adequate cardiac function documented by left ventricular ejection fraction (LVEF).
  • Adequate renal function with creatinine < 1.5 mg/dl.

Exclusion Criteria:

  • Previous chemotherapy, hormone therapy and/or radiotherapy for breast cancer.
  • Bilateral breast cancer. Lobular in situ carcinoma.
  • Previous or current malignancies, except for basal skin carcinoma, cervical in situ carcinoma or superficial bladder carcinoma, adequately treated.
  • History of arrhythmias and/or congestive heart failure or cardiac blocking grade 2-3; history of myocardial infarction in 6 months before recruitment.
  • Inability for treatment and study compliance.
  • Pregnant or lactating women.
  • Active infection.
  • History of hypersensitivity to cremophor or cyclosporine.
  • Pre-existing grade 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria [NCI CTC]).
  • Hormonal receptor status not determined.
  • Any other criteria which, in investigator's opinion, may jeopardize patient's security or compliance.
  • Administration of other investigational product in the 30 days prior to randomisation; current participation in another clinical trial.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 70 Years   (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 Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00129922
Other Study ID Numbers  ICMJE GEICAM 9906
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spanish Breast Cancer Research Group
Study Sponsor  ICMJE Spanish Breast Cancer Research Group
Collaborators  ICMJE
  • Bristol-Myers Squibb
  • Pfizer
  • Hoffmann-La Roche
Investigators  ICMJE
Study Director:Study DirectorHospital General Universitario de Elche
Study Director:Study DirectorHospital Universitario Marqués de Valdecilla
Study Director:Study DirectorHospital Provincial de Córdoba
PRS Account Spanish Breast Cancer Research Group
Verification Date February 2019

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