Study of Docetaxel in Breast Cancer Patients

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