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Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer
Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer

NCT00129922

CompletedPhase 3

Sponsor: Spanish Breast Cancer Research Group

Conditions: Breast Cancer

Interventions: paclitaxel, Fluorouracil, Epirubicin, Cyclophosphamide

Countries: Spain

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (64)
  • Alcoy, Alicante, Spain
  • Elche, Alicante, Spain
  • Elda, Alicante, Spain
  • Badalona, Barcelona, Spain
  • Badalona, Barcelona, Spain
  • Manresa, Barcelona, Spain
  • Sabadell, Barcelona, Spain
  • Santa Coloma de Gramenet, Barcelona, Spain
  • Terrassa, Barcelona, Spain
  • Terrassa, Barcelona, Spain
  • Santander, Cantabria, Spain
  • Jerez de la Frontera, Cádiz, Spain
  • Puerto Real, Cádiz, Spain
  • Donostia / San Sebastian, Gupúzcoa, Spain
  • Donostia / San Sebastian, Gupúzcoa, Spain
  • Barbastro, Huesca, Spain
  • Las Palmas de Gran Canaria, Las Palmas, Spain
  • Las Palmas de Gran Canaria, Las Palmas, Spain
  • Alcorcón, Madrid, Spain
  • Majadahonda, Madrid, Spain
  • Móstoles, Madrid, Spain
  • El Palmar, Murcia, Spain
  • Pamplona, Navarre, Spain
  • Gijón, Principality of Asturias, Spain
  • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
  • Reus, Tarragona, Spain
  • Alzira, Valencia, Spain
  • Sagunto, Valencia, Spain
  • Barakaldo, Vizcaya, Spain
  • A Coruña, Spain
  • + 34 more on CT.gov