Clinical trial NCT00548899 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: nexavar (sorafenib)
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Unilateral or bilateral primary carcinoma of the breast,

          -  Tumor lesion in the breast with a palpable size of >= 2 cm. The lesion has to be
             measurable in two-dimensions preferably by sonography. In case of inflammatory disease
             the extent of inflammation can be used as measurable lesion;

          -  Patients should have stages of disease in which adjuvant chemotherapy would be
             considered.

          -  Women of childbearing potential must have a negative serum pregnancy test

          -  Negative HER-2/neu status

          -  Karnofsky Performance status index >= 80%;

          -  Normal cardiac function

          -  Laboratory requirements:

        Absolute neutrophile count (ANC) >= 2,0 x 109/L and Platelets >= 100 x 109/L and Hemoglobin
        >= 10 g/dL (>= 6.2 mmol/L) INR ≤ 1.5 ULN and PTT ≤ 1.5 ULN within 14 days prior to
        enrolment ASAT or ALAT < 2.5 x ULN Alkaline phosphatase ≤ 5 UNL. Patients with ASAT and/or
        ALAT > 1,5 x UNL associated with alkaline phosphatase > 2,5 x UNL are not eligible for the
        study Total bilirubin < 1 X UNL Creatinine ≤ 175 µmol/L (2 mg/dl). The calculated
        creatinine clearance should be ≥ 60 mL/min.

        Paraffin tumor tissue block and each one serum and one plasma sample centrally made
        available

          -  Complete staging work-up within 3 months prior to registration.

          -  Patients must be available and compliant for treatment and follow-up. Patients
             registered on this trial must be treated and followed up at the participating or a
             cooperating center.

        Exclusion Criteria:

          -  Patients with low or moderate risk, which are only doubtful candidates for adjuvant
             chemotherapy and do not fulfil the inclusion criteria No. 5.

          -  Evidence of distant metastasis;

          -  Prior chemotherapy for any malignancy;

          -  Prior radiation therapy for breast cancer;

          -  Preexisting rhagades at hand and feet and other skin problems (e.g. psoriasis)

          -  Pregnant or lactating patients.

          -  Pre-existing motor or sensory neuropathy of a severity >= grade 2 by NCI criteria; 7.
             Concurrent treatment with: Chronic corticosteroids unless initiated > 6 months prior
             to study entry and at low dose (< 20 mg methylprednisolone or equivalent); Sex
             hormones. Prior treatment must be stopped before study entry; Patients with increased
             risk of bleeding due to concurrent therapeutic or prophylactic anticoagulative
             treatment. Low dose of coumarines are permitted.

        Other experimental drugs or any other anti-cancer therapy; Drugs recognized as being strong
        inhibitors or inducers of the isoenzyme CYP3A within the last 5 days or their expected need
        8. Other serious illness or medical condition:

          -  Previous malignant disease without being disease-free of less than 5 years (except CIS
             of the Cervix and non-melanomatous skin cancer)

          -  Known or suspected congestive heart failure (≥NYHA II) and/or coronary heart disease,
             angina pectoris requiring antianginal medication, previous history of myocardial
             infarction, evidence of transmural infarction on ECG, un- or poorly controlled
             arterial hypertension, rhythm abnormalities requiring permanent treatment, clinically
             significant valvular heart disease

          -  Thrombotic or embolic events

          -  Hemorrhage/bleeding event ≥ Grade 3 within 4 weeks prior study entry

          -  Evidence or history of bleeding diathesis or coagulopathy

          -  History of significant neurological or psychiatric disorders

          -  Patients with seizure disorders requiring medication such as steroids or
             antiepileptics

          -  Currently active infection

          -  History of HIV infection or chronic hepatitis B or C

          -  Serious non healing wound, ulcer or bone fracture

          -  Patients with prior immunosuppressive treatment

          -  Severe pulmonary condition/illness

          -  Disease significantly affecting gastrointestinal function,

          -  Patients with severe liver disease

          -  Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
             dose of study drug

          -  Definite contraindications for the use of corticosteroids

          -  Inadequate general condition (not fit for anthracycline/taxane-containing
             chemotherapy)