Inclusion Criteria:

1. Female patient with histologically or cytologically documented breast adenocarcinoma

2. First local or metastatic relapse

3. Patients must have received a prior neoadjuvant or adjuvant Taxotere®-based
chemotherapy regimen, provided this chemotherapy was completed > than or = to 12
months prior to enrollment date

4. Prior hormone or immune therapy is allowed. Antitumoral adjuvant hormone therapy may
be continued during the study period, provided it was started > 12 months prior to
study enrollment

5. Her2/neu negative tumor demonstrated by immunohistochemistry (IHC 0 or 1+) or by
fluorescence in situ hybridation (FISH -). A patient with tumor assessed as 2+ by IHC
can be enrolled if the tumor is negative by FISH.

6. ECOG performance status of 0 to 2

7. Normal cardiac function confirmed by LVEF or shortening fraction (MUGA scan or
echocardiography, respectively, within normal limits for the institution) assessed
within 3 months prior to study entry. An ECG must be obtained within 4 weeks prior
study entry and must demonstrate no clinically significant abnormality.

8. Patients are required to have at least one measurable lesion according to RECIST
guidelines

9. Adequate organ function defined by:

1. Hematology: Neutrophils > than or = to 2.0 109/L, Platelets > than or = to 100
109/L, Hemoglobin > than or = to 10 g/dL

2. Hepatic function: Total bilirubin within normal limits, AST (SGOT) and ALT
(SGPT) < than or = to 1.5 UNL, alkaline phosphatase < than or = to 2.5 UNL
(unless accompanied by extensive bone metastases)

10. Negative pregnancy test (urine or serum) within 7 days prior to registration for all
women of childbearing potential

11. Written informed consent prior to beginning specific protocol procedures must be
obtained and documented according to the local regulatory requirements

Exclusion Criteria

1. Prior therapy for advanced or recurrent disease

2. Previous cumulative exposure to epirubicin > 600 mg/m² or to doxorubicin > 300 mg/m²

3. Previous radiation therapy having involved more than 25% of bone marrow; incomplete
recovery from toxicity of radiation therapy

4. Symptomatic brain metastases and clinically diagnosed leptomeningeal metastases

5. Isolated unmeasurable bone lesions, serous pleural effusion or pulmonary
lymphangiitis (i.e., unmeasurable disease according to the RECIST guidelines)

6. Pre-existing motor or sensory neurologic toxicity of a severity > than or = to grade
2 according to NCI-CTC AE criteria version 3.0

7. Pregnant or lactating women or women of childbearing potential not using adequate
contraception

8. Other serious illness or medical conditions, including:

1. Congestive heart failure or unstable angina pectoris, previous history of
myocardial infarction within 1 year from study entry, uncontrolled hypertension
or high-risk uncontrolled arrhythmias

2. History of significant neurologic or psychiatric disorders including psychotic
disorders, dementia or seizures that would hamper understanding and giving
informed consent.

3. Active uncontrolled infection

4. Active peptic ulcer, uncontrolled diabetes mellitus

9. Past or current history of neoplasm other than breast carcinoma, except:

1. Curatively treated non-melanoma skin cancer.

2. in situ carcinoma of the cervix.

3. Other cancer curatively treated and with no evidence of disease for at least 10
years

10. Chronic treatment with corticosteroids unless initiated > 6 months prior to study
entry and at low dose (< than or = to 20 mg methylprednisolone per day or equivalent)

11. Definite contraindications for the use of corticosteroids

12. Likelihood of requiring treatment during the study period with drugs not permitted by
the clinical study protocol (see Section 6.2)

13. Concurrent treatment with other investigational drugs. Active treatment as part of
another clinical therapeutic trial within 30 days prior to study entry

14. Concurrent treatment with any other anti-cancer therapy, except adjuvant hormone
therapy started > than or = to 12 months prior to study enrollment. Bisphosphonates
for management of bone metastases or osteoporosis/osteopenia are allowed

15. History of hypersensitivity to docetaxel (or drugs formulated in polysorbate 80),
epirubicin or doxorubicin

16. Mental condition rendering the subject unable to understand the nature, scope, and
possible consequences of the study

17. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to
return for follow-up visits, and unlikelihood of completing the study

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.