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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Breast Cancer Research Group
• Collaborators: Bristol-Myers Squibb; Hoffmann-La Roche; Pfizer
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Epirubicin; Fluorouracil; Paclitaxel

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.