Inclusion Criteria:

1. newly diagnosed histologically confirmed BC with breast infiltrating carcinoma of
histological grade > 1 (either operable, or locally advanced or inflammatory)
candidate for neoadjuvant chemotherapy

2. HER2-negative tumor, defined according to immunohistochemistry or using fluorescent
in-situ hybridization (FISH)

3. ECOG performance status 0 or 1

4. Gender: female

5. Age : >= 18 years old

6. Negative pregnancy test (females of childbearing potential)

7. Willingness to perform double-barrier-contraception during study and for 6 months
post chemotherapy treatment (females of childbearing potential)

8. Signed informed consent

Exclusion Criteria:

1. Metastatic or relapsed disease

2. Major surgery < 3 weeks prior to enrollment

3. Severe pulmonary obstructive or restrictive disease

4. Uncontrolled inflammatory disease (autoimmune or infectious)

5. Clinically significant cardiac disease (NYHA stadium > 2)

6. Results of laboratory tests (hematology, chemistry) outside specified limits:

- WBC ≤ 3 x 109/L

- ANC < 1.5 x 109/L

- Platelets < 100 x 109/L

- Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)

- PTT/ INR > 1.5 x ULN

- AST or ALT > 2.5 x ULN

- Alkaline Phosphatase > 2 x ULN

- Total Bilirubin > 1.5 x ULN

7. Pregnancy or nursing status

8. Known positive HIV testing

9. Known hypersensitivity to any component of the EndoTAG-1, paclitaxel or FEC
formulations

10. History of malignancy other than breast cancer < 5 years prior to enrollment, except
skin cancer (i.e. basal or squamous cell carcinoma) treated locally

11. History of active or significant neurological disorder or psychiatric disorder that
would prohibit the understanding and giving of informed consent, or would interfere
in the clinical and radiological evaluation of central nervous system during the
trial

12. Concurrent treatment with other experimental products. Participation in another
clinical trial with any investigational product within 30 days prior to study entry