Clinical trial NCT00066443 (phase 1/phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: docetaxel, epirubicin hydrochloride
SMILES: [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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed invasive adenocarcinoma of the breast, meeting any of the
             following criteria:

               -  T4, NX, M0

               -  Any T, N2-N3, M0

               -  Inflammatory breast cancer (redness over at least one-third of the breast), M0

          -  No evidence of metastatic disease by chest x-ray, abdominal ultrasound or CT scan and
             bone scan

          -  Diagnosed within the past 8 weeks

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  16 and over

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute granulocyte count at least 2,000/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 10 g/dL

        Hepatic

          -  Bilirubin less than upper limit of normal (ULN)

          -  Must meet criteria for 1 of the following:

               -  ALT and AST no greater than 1.5 times ULN AND alkaline phosphatase no greater
                  than 2.5 times ULN

               -  ALT and AST normal AND alkaline phosphatase no greater than 5 times ULN

        Renal

          -  Creatinine no greater than 1.5 times ULN

        Cardiovascular

          -  Resting LVEF normal by MUGA or echocardiogram

          -  No congestive heart failure

          -  No angina pectoris

          -  No myocardial infarction within the past year

          -  No uncontrolled hypertension

          -  No uncontrolled arrhythmias

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective non-hormonal contraception

          -  No other malignancy within the past 5 years except adequately treated nonmelanoma skin
             cancer or curatively treated carcinoma in situ of the cervix

          -  No symptomatic peripheral neuropathy grade 2 or greater

          -  No active infection

          -  No history of significant neurological or psychiatric disorders, including dementia or
             seizures

          -  No peptic ulcer

          -  No unstable diabetes mellitus

          -  No contraindication to dexamethasone

          -  No known sensitivity to E. coli-derived or polyethylene glycol products

          -  Willing to undergo core biopsies once prior to registration and core biopsies at 2
             other timepoints while on study

          -  Geographically accessible for treatment and follow-up

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior immunotherapy for breast cancer

        Chemotherapy

          -  No prior chemotherapy for breast cancer

        Endocrine therapy

          -  No prior hormonal therapy for breast cancer

          -  No concurrent corticosteroids except for premedication or hypersensitivity reaction

          -  No concurrent oral contraception

        Radiotherapy

          -  No prior radiotherapy for breast cancer

        Surgery

          -  No prior surgery for breast cancer other than biopsy

        Other

          -  No prior systemic therapy for breast cancer

          -  No other concurrent investigational drugs or anticancer treatment

          -  No concurrent preventative IV antibiotics