Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00129922
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1289
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluorouracil+Epirubicin+Cyclophosphamide Fluorouracil 5-FU+4-Epirubicin+Cyclophosphamide Fluorouracil+Epirubicin+Cyclophosphamide Epirubicin 5-FU+4-Epirubicin+Cyclophosphamide Fluorouracil+Epirubicin+Cyclophosphamide Cyclophosphamide 5-FU+4-Epirubicin+Cyclophosphamide FEC followed by Paclitaxel paclitaxel 5-FU+4-Epirubicin+Cyclophosphamide FEC followed by Paclitaxel Fluorouracil 5-FU+4-Epirubicin+Cyclophosphamide FEC followed by Paclitaxel Epirubicin 5-FU+4-Epirubicin+Cyclophosphamide FEC followed by Paclitaxel Cyclophosphamide 5-FU+4-Epirubicin+Cyclophosphamide
- Primary Outcome Measures
Name Time Method disease-free survival 5 years From the date of randomization of each patient included to the 1st documented evidence of recurrence
- Secondary Outcome Measures
Name Time Method Overall survival 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
Related Research Topics
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Trial Locations
- Locations (64)
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Hospital Universitario Puerto Real
🇪🇸Puerto Real, Cádiz, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
🇪🇸Las Palmas De Gran Canaria, Las Palmas, Spain
Hospital Donostia
🇪🇸Donostia-San Sebastian, Gupúzcoa, Spain
Hospital de Sagunto
🇪🇸Sagunto, Valencia, Spain
Hospital General Universitario de Elda
🇪🇸Elda, Alicante, Spain
Hospital de Cabueñes
🇪🇸Gijón, Asturias, Spain
Corporació Sanitaria Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital Espíritu Santo
🇪🇸Santa Coloma De Gramenet, Barcelona, Spain
Hospital de Barbastro
🇪🇸Barbastro, Huesca, Spain
Hospital Universitario San Joan de Reus
🇪🇸Reus, Tarragona, Spain
Hospital Unviersitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario Virgen de los Lirios
🇪🇸Alcoy, Alicante, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital Universitario Mutua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Althaia-Xarxa Assistencial de Manresa
🇪🇸Manresa, Barcelona, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
🇪🇸Las Palmas De Gran Canaria, Las Palmas, Spain
Hospital Universitario Puerta del Mar
🇪🇸Cádiz, Spain
Hospital Rio Carrión
🇪🇸Palencia, Spain
Hospital Provincial de Toledo
🇪🇸Toledo, Spain
Hospital Provincial de Zamora
🇪🇸Zamora, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Onkologikoa
🇪🇸Donostia-San Sebastián, Gupúzcoa, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Hospital Universitario de Móstoles
🇪🇸Móstoles, Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Centro Oncológico de Galicia
🇪🇸A Coruña, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital General Universitario de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital General Universitario de Guadalajara
🇪🇸Guadalajara, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital General Universitario Morales Meseguer
🇪🇸Murcia, Spain
Hospital Clínico Unviersitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Clínico Universitario San Carlos
🇪🇸Madrid, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Hospital de León
🇪🇸León, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain
Hospital Unviersitario de Salamanca
🇪🇸Salamanca, Spain
Complejo Hospitalario de Ourense
🇪🇸Ourense, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Arnau de Vilanova de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Zaragoza "Lozano Blesa"
🇪🇸Zaragoza, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Clínica Oncológica Corachán
🇪🇸Barcelona, Spain
Hospital Municipal de Badalona
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Santa Cruz De Tenerife, Spain
Hospital de la Ribera
🇪🇸Alcira, Valencia, Spain
Hospital Universitario Cruces
🇪🇸Baracaldo, Vizcaya, Spain
Hospital Provincial de Córdoba
🇪🇸Córdoba, Spain
Hospital de Txagorritxu
🇪🇸Vitoria-Gasteiz, Álava, Spain
Consorci Sanitari de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital de Jerez de la Frontera
🇪🇸Jerez De La Frontera, Cádiz, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain