Inclusion Criteria

Inclusion criteria:

- Histologically proven breast cancer at the first diagnosis with > or = 4 axillary
nodes showing evidence of tumor among a minimum of 10 resected lymph nodes (American
Joint Committee on Cancer 1992 pathologic staging pT1-4, pN1-2 [at least 1/10], M0)

- Ages ≥ 18 years and ≤ 70 years for patients who will be randomized to arm A and B.
Ages ≥ 18 years and ≤ 65 years for patients who will be randomized to arm C

- World Health Organization performance status 0-1

- Definitive surgical treatment must be either mastectomy or breast conserving surgery,
with axillary lymph node dissection for operable breast cancer (clinical T1-3, N1,
M0). Margins of resected specimen from definitive surgery must be histologically free
of invasive adenocarcinoma and ductal carcinoma in situ. Lobular carcinoma in situ
does not count as a positive margin. Patients with histologically-documented
infiltration of the skin (pT4a) will be also eligible

- Surgical procedures completed within 8 weeks from the randomization.

- Laboratory requirements:

- Hematology :

- Neutrophils ≥ 2 x 10^9/L

- Platelets ≥ 100 x 10^9/L

- Hemoglobin ≥ 10 g/DL

- Hepatic function:

- Total bilirubin ≤ 1 time the upper-normal limits of the institutional
normal values.

- ASAT & ALAT ≤ 2.5 UNL, alkaline phosphatase ≤ 5 UNL. Patients with ASAT
&/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are
not eligible for the study

- Renal function :

- Creatinine ≤ 140 µmol/L (1.6 mg/DL); if limit values, the creatinine
clearance should be performed and should be ≥ 60 ml/min

- Normal left ventricular ejection fraction or superior to the lower limits of the
institution

- Patients must be accessible for treatment and follow-up. Patients registered on this
trial must be treated and followed at the participating center

- Complete work-up within 3 months prior to randomization. All patients will have
bilateral mammography, chest X rays (posteroanterior [PA] and lateral), abdominal
ultrasound and/or computed tomography scan, & bone scan

Exclusion criteria:

- Axillary lymph nodes free of involvement

- Primary breast cancer with histology other than adenocarcinoma

- Inflammatory carcinoma

- Any locally advanced (T4 and/or N2-known N3) or metastatic (M1) breast cancer

- Past or current history of ipsilateral or contralateral invasive or contralateral
ductal in situ breast carcinoma. A past or current history of ipsilateral ductal in
situ or lobular in situ (ipsilateral or contralateral) breast carcinoma is not an
exclusion criterion

- Histologically positive resection margins. Patients undergoing conservative resection
margins can be considered eligible if radically resected within 4 weeks from
randomization

- Pregnant or lactating women or women of childbearing potential (e.g. not using
adequate contraception)

- History of prior or concomitant malignancies other than curatively treated basal cell
skin cancer or excised cervical carcinoma in situ

- Symptomatic peripheral neuropathy > grade 2 according to the National Cancer
Institute Common Toxicity Criteria

- Other serious illnesses or medical conditions:

- Congestive heart failure or angina pectoris even if it is medically controlled.
Previous history of myocardial infarction within 1 year from study entry,
uncontrolled high risk hypertension or arrhythmias

- History of significant neurologic or psychiatric disorders including dementia or
seizures

- Active infection

- Peptic ulcer, unstable diabetes mellitus or other contraindications for the use
of dexamethasone

- Concurrent treatment with other experimental drugs. Participation in another clinical
trial with any investigational regimen within 30 days prior to study entry

- Concurrent treatment with any other anti-cancer therapy

- Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment
should be stopped before study entry

- Prior systemic anticancer therapy for breast cancer (chemotherapy, hormonal therapy,
immunotherapy, etc.) as adjuvant and/or neo-adjuvant therapy

- Concomitant treatment with corticosteroids used for reasons other than premedication;
however, patients receiving chronic treatment with corticosteroids (>6 months) at low
dose (≤ 20 mg of methylprednisolone or equivalent dose of other corticosteroids) for
whichever reason are eligible

- Definite contraindications for the use of corticosteroids as premedication

- Prior radiation therapy

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