A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-Fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes
- 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
- 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
- Age between 18 years and 70 years.
- Karnofsky performance status index > 80 %.
- Adequate hepatic, renal and heart functions.
- Adequate hematology levels.
- Negative pregnancy test
- Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy,
- 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.