Status:
COMPLETED
Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Bristol-Myers Squibb
Pfizer
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
1289 Patients enrolled
Trial Details
Trial ID
NCT00129922
Start Date
November 1 1999
End Date
December 1 2007
Last Update
March 6 2023
Active Locations (64)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Virgen de los Lirios
Alcoy, Alicante, Spain, 03804
2
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
3
Hospital General Universitario de Elda
Elda, Alicante, Spain, 03600
4
Hospital Municipal de Badalona
Badalona, Barcelona, Spain, 08911