Neoadjuvant Chemotherapy Including Sorafenib in Women With Previously Untreated Primary Breast Cancer

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)