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

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ClinicalTrials.gov Identifier: NCT00129922
Recruitment Status : Active, not recruiting
First Posted : August 12, 2005
Last Update Posted : March 19, 2018
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pfizer
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: paclitaxel Drug: Fluorouracil Drug: Epirubicin Drug: Cyclophosphamide Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 1289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 1999
Actual Primary Completion Date : December 2005
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Fluorouracil+Epirubicin+Cyclophosphamide
5-FU+4-Epirubicin+Cyclophosphamide
Drug: Fluorouracil
Other Name: 5-FU
Drug: Epirubicin
Other Name: 4-Epirubicin
Drug: Cyclophosphamide
Experimental: FEC followed by Paclitaxel
5-FU+4-Epirubicin+Cyclophosphamide
Drug: paclitaxel
Other Name: Taxol
Drug: Fluorouracil
Other Name: 5-FU
Drug: Epirubicin
Other Name: 4-Epirubicin
Drug: Cyclophosphamide



Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 5 years ]
    From the date of randomization of each patient included to the 1st documented evidence of recurrence


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 100 months ]
    Overall survival will be measured from the day of randomization to the date of death from any cause



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129922


  Show 64 Study Locations
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Bristol-Myers Squibb
Pfizer
Hoffmann-La Roche
Investigators
Study Director: Study Director Hospital General Universitario de Elche
Study Director: Study Director Hospital Universitario Marqués de Valdecilla
Study Director: Study Director Hospital Provincial de Córdoba

Additional Information:
Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00129922     History of Changes
Other Study ID Numbers: GEICAM 9906
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Keywords provided by Spanish Breast Cancer Research Group:
Axillary node positive breast cancer.
Sequential drug administration.
Weekly paclitaxel.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Fluorouracil
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors