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Fluorouracil, Epirubicin, and Cyclophosphamide (FEC) Versus FEC Plus Paclitaxel as Adjuvant Treatment for Node Positive Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT00129922
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : September 27, 2005
Bristol-Myers Squibb
Hoffmann-La Roche
Information provided by:
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 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Phase III Clinical Trial 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 Breast Cancer Patients
Study Start Date : November 1999
Estimated Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 5-year disease-free survival

Secondary Outcome Measures :
  1. Overall survival

Information from the National Library of Medicine

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

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

Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Bristol-Myers Squibb
Hoffmann-La Roche
Study Chair: Álvaro Rodríguez-Lescure, MD Spanish Breast Cancer Research Group (GEICAM)
Study Chair: José Manuel López-Vega, MD Spanish Breast Cancer Research Group (GEICAM)
Study Chair: Enrique Aranda, MD Spanish Breast Cancer Research Group (GEICAM)

Additional Information:
ClinicalTrials.gov Identifier: NCT00129922     History of Changes
Other Study ID Numbers: GEICAM 9906
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: September 27, 2005
Last Verified: August 2005

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
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
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, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors