Clinical trial NCT00047099 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: cyclophosphamide, docetaxel, epirubicin hydrochloride, fluorouracil, goserelin acetate, tamoxifen citrate
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, 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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O, COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of primary epithelial invasive carcinoma of the breast

               -  T1-4, N1-2, M0

               -  Must have 4 metastatic axillary lymph nodes

          -  Complete resection of the primary tumor within the past 5 weeks

               -  Free of invasive carcinoma with at least 10 lymph nodes removed

          -  No inflammatory breast cancer

          -  No distant metastases by chest x-ray, liver ultrasound, and whole body bone scan

          -  Hormone receptor status:

               -  Estrogen and/or progesterone receptor status known

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 70

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  At least 32 weeks

        Hematopoietic

          -  WBC at least 3,000/mm3

          -  Platelet count at least 100,000

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  SGOT/SGPT no greater than 1.5 times ULN

          -  Alkaline phosphatase no greater than 1.5 times ULN

          -  Albumin no greater than 1.5 times ULN

        Renal

          -  Creatinine no greater than 1.5 times ULN

        Cardiovascular

          -  No cardiomyopathy with impaired ventricular function

          -  No New York Heart Association class III or IV heart disease

          -  No cardiac arrhythmias influencing LVEF and requiring medication

          -  No myocardial infarction within the past 6 months

          -  No angina pectoris within the past 6 months

          -  No uncontrolled arterial hypertension

        Other

          -  No other primary malignancy except carcinoma in situ of the cervix or adequately
             treated basal cell skin cancer

          -  No known hypersensitivity to docetaxel, epirubicin, fluorouracil, cyclophosphamide, or
             other study medication

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior cytotoxic or other antineoplastic therapy

          -  No other concurrent cytotoxic or other antineoplastic therapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy

        Surgery

          -  See Disease Characteristics

        Other

          -  At least 3 weeks since prior investigational agents