Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients

Inclusion criteria

• Histologically or cytologically confirmed breast adenocarcinoma.
• Within 20-45 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
• Absence of lymph node involvement after eclosion and hormone (E&H) staining and light microscopy evaluation.
• Premenopausal or postmenopausal women with at least one of the following tumor characteristics is required in order to characterize the tumor as high risk:

• Estrogen receptor (ER) (-) and progesterone receptor (PR)(-);
• Ki-67 + > 30%; Grade III; HER2 (3+) (after an amendment on 15.05.2008 women with HER2 (3+) were not included); Perineural infiltration or presence of tumor emboli in blood or lymph vessels.
• Postmenopausal women with tumors 1-2 cm are eligible if the tumor has at least 2 of the above mentioned high risk criteria.
• Premenopausal and postmenopausal women with tumors measuring > 2 cm are eligible irrespectively of the expression of the above adverse prognostic tumor criteria.
• Absence of any clinical or radiological evidence of local or metastatic disease.
• Age > 18 years.
• Performance status (WHO) < 3.
• Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3).
• Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl).
• Adequate cardiac function (LVEF > 50%).
• Negative pregnancy test.
• Informed consent.

Exclusion criteria

• Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
• Other concurrent uncontrolled illness that could affect compliance with the study.
• Psychiatric illness or social situation that would preclude study compliance.
• Pregnant or nursing women.
• History of allergic reaction attributed to docetaxel.
• Other concurrent investigational agents.