Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer
NCT00129922
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- 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.
- 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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| Descriptive Information | ||||||||||
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| 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 |
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| Study Arms ICMJE |
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| Publications * |
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* 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 | 1289 | |||||||||
| Original Enrollment ICMJE | 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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| Investigators ICMJE |
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| 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 | ||||||||||