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

GEICAM 9906

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.

1999-11-01

2005-12-01

2007-12-01

Completed

Early phase I

1289

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.

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2023-03-06