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

NCT00129922

Last updated date
Study Location
Hospital Universitario Virgen de los Lirios
Alcoy, Alicante, 03804, Spain
Contact
1-800-718-1021

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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.

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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