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
- 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
- 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
- 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.