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