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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


Phase 3
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

5-year disease-free survival

Principal Investigator

Álvaro Rodríguez-Lescure, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Spanish Breast Cancer Research Group (GEICAM)

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GEICAM 9906

NCT ID:

NCT00129922

Start Date:

November 1999

Completion Date:

July 2007

Related Keywords:

  • Breast Cancer
  • Axillary node positive breast cancer.
  • Sequential drug administration.
  • Weekly paclitaxel.
  • Breast Neoplasms

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