Clinical trial NCT00121992 (phase 3, status: completed)
Conditions: breast neoplasms
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: docetaxel, 5-fluorouracil, doxorubicin, cyclophosphamide
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, FC1=CNC(=O)NC1=O, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, ClCCN(CCCl)P1(=O)NCCCO1
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.