Docetaxel, Doxorubicin (A), Cyclophosphamide (C) (TAC) vs 5-Fluorouracil, A, C (5FAC) Breast Cancer Adjuvant Treatment
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Docetaxel; 5-fluorouracil; Doxorubicin; Cyclophosphamide
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Fluorouracil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1060.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: High risk node negative breast cancer; Disease-Free survival; Quality of life

Summary:

      This is a prospective, non-blinded randomized phase III trial. Patients will be
      post-surgically stratified at inclusion first according to the participating institution,
      then according to menopausal status and will be randomly assigned to receive either:

        -  TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks
           (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500
           mg/m2 as an i.v. bolus on day 1 every 3 weeks.

        -  FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination
           with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v.
           bolus on day 1 every 3 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10
             axillary nodes dissection) and high risk criteria according to St. Gallen consensus
             criteria.

          -  Histologically proven breast cancer. Interval between surgery and registration is less
             than 60 days.

          -  Definitive surgical treatment must be either mastectomy, or breast conservative
             surgery. Margins of resected specimen from surgery must be histologically free of
             invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ
             is not considered as positive margin.

          -  Patients without proven metastatic disease.

          -  Estrogen and progesterone receptors performed on the primary tumour prior to
             randomization.

          -  Age between 18 years and 70 years.

          -  Karnofsky performance status index > 80 %.

          -  Adequate hepatic, renal and heart functions.

          -  Adequate hematology levels.

          -  Negative pregnancy test

        Exclusion Criteria:

          -  Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy,
             chemotherapy).

          -  Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.

          -  Prior radiation therapy for breast cancer.

          -  Bilateral invasive breast cancer.

          -  Pregnant, or lactating patients.

          -  Patients of childbearing potential must implement adequate non-hormonal contraceptive
             measures during study treatment .

          -  Any T4 or N1-3 or M1 breast cancer.

          -  Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria.

          -  Other serious illness or medical condition

          -  Past or current history of neoplasm other than breast carcinoma.

          -  Ipsilateral ductal carcinoma in-situ (DCIS) of the breast.

          -  Lobular carcinoma in-situ (LCIS) of the breast.

          -  Chronic treatment with corticosteroids unless initiated > 6 months prior to study
             entry and at low dose

          -  Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should
             be stopped before study entry.

          -  Definite contraindications for the use of corticosteroids.

          -  Concurrent treatment with other experimental drugs.

          -  Participation in another clinical trial with any investigational not marketed drug
             within 30 days prior to study entry.

          -  Concurrent treatment with any other anti-cancer therapy.

          -  Male patients.