Clinical trial NCT01093235 (phase 3, status: unknown status)
Conditions: breast cancer, cardiac toxicity, perioperative/postoperative complications
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: cyclophosphamide, docetaxel, epirubicin hydrochloride, fluorouracil
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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed invasive breast cancer

          -  HER2-negative disease

               -  IHC 0/1 OR IHC 2+ and FISH negative

          -  Must meet 1 of the following criteria:

               -  Unifocal tumor meeting 1 of the following criteria:

                    -  T2 or T3 tumors (radiological size > 20 mm)

                    -  T4 tumor of any size with direct extension to the chest wall or the skin

                    -  Inflammatory carcinoma with tumor of any size

               -  Multifocal tumor meeting the following criteria:

                    -  The sum of each tumors' maximum diameter must be ≥ 20 mm (total radiological
                       tumor size ≥ 20 mm)

               -  Other locally advanced disease meeting 1 of the following criteria:

                    -  Any T stage with involvement of large or fixed axillary lymph nodes
                       (radiological diameter > 20 mm or clinical N2) and primary breast tumor of
                       any diameter

                    -  Any T stage with involvement of large or fixed axillary lymph nodes
                       (radiological diameter > 20 mm or clinical N2), without a primary breast
                       tumor identified and the presence of breast cancer in a lymph node must be
                       histopathologically confirmed by lymph node biopsy (tru-cut or whole lymph
                       node)

          -  Embedded paraffin tumor block available from pre-chemotherapy biopsy and surgical
             specimen

          -  Bilateral disease allowed

          -  No evidence of metastatic disease

          -  No prior breast cancer except for ductal carcinoma in situ of the breast surgically
             cured > 10 years ago

          -  Any hormone receptor status

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  WBC > 3 x 10^9/L

          -  Hemoglobin > 10 g/dL

          -  Platelet count > 100 x 10^9/L

          -  AST/ALT ≤ 1.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2 times ULN

          -  Bilirubin normal

               -  Isolated elevation of bilirubin to ≤ 3 times ULN with a presumptive diagnosis of
                  Gilbert syndrome allowed if AST/ALT and alkaline phosphatase are within normal
                  limits

          -  Creatinine ≤ 1.5 times ULN

          -  PT and PTT/aPTT ≤ 1.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception

          -  Must be fit to receive chemotherapy on this trial, in the opinion of the responsible
             clinician, as indicated by the following criteria:

               -  No clinically significant cardiac abnormalities

               -  No myocardial infarction within the past 6 months

               -  LVEF normal (at least 50%) by MUGA scan or echocardiogram

          -  No prior ischemic heart disease, cerebrovascular disease, peripheral vascular disease,
             arterial or venous thromboembolic disease, cardiac failure, inflammatory bowel
             disease, gastroduodenal ulcer, symptomatic diverticulitis, or bleeding diathesis

          -  No uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg) with
             or without antihypertensive medication

               -  Patients with initial blood pressure elevations are eligible provided initiation
                  or adjustment of antihypertensive medication lowers pressure to meet entry
                  criteria

          -  No other previous malignancy except basal cell carcinoma, carcinoma in situ of the
             cervix, or ductal carcinoma in situ of the breast treated by surgery only and
             disease-free for 10 years

          -  No concurrent medical or psychiatric problem that might prevent completion of
             treatment or follow-up

          -  No presence of active uncontrolled infection

          -  No history of nephritic or nephrotic syndrome

          -  No traumatic injury within the past 28 days

          -  No evidence of other disease that, in the opinion of the investigator, places the
             patient at high risk of treatment-related complications

          -  No nonhealing wound, peptic ulcer, or bone fracture

        PRIOR CONCURRENT THERAPY:

          -  No prior neoadjuvant endocrine therapy

          -  No prior chemotherapy or radiotherapy

          -  No major surgical procedure within the past 28 days

          -  No concurrent full therapeutic dose of anticoagulants or aspirin > 325 mg/day,
             clopidogrel > 75 mg/day, or corticosteroids