Fluorouracil, Epirubicin, and Cyclophosphamide (FEC) Versus FEC Plus Paclitaxel as Adjuvant Treatment for Node Positive Breast Cancer Patients
This study has been completed.
Sponsor:
Spanish Breast Cancer Research Group
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
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Fluorouracil
Paclitaxel
Epirubicin hydrochloride
Epirubicin
U.S. FDA Resources
Further study details as provided by Spanish Breast Cancer Research Group:
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
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 Antimetabolites Antimetabolites, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 21, 2013