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

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pfizer
Hoffmann-La Roche
Information provided by:
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00129922
First received: August 10, 2005
Last updated: September 26, 2005
Last verified: August 2005
  Purpose

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 Intervention Phase
Breast Cancer
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:
  • 5-year disease-free survival

Secondary Outcome Measures:
  • Overall survival

Estimated Enrollment: 1250
Study Start Date: November 1999
Estimated Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129922

Locations
Spain
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
Pfizer
Hoffmann-La Roche
Investigators
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)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00129922     History of Changes
Other Study ID Numbers: GEICAM 9906
Study First Received: August 10, 2005
Last Updated: September 26, 2005
Health Authority: Spain: Spanish Agency of Medicines

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
Cyclophosphamide
Fluorouracil
Epirubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 11, 2014