A Multicenter Randomized Phase III Study of Adjuvant Treatment With Epirubicin Followed by Docetaxel (E/T) Versus Epirubicin and Docetaxel Combination (ET) in High Risk Lymph Node Negative Breast Cancer Patients
- 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
- 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+);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.
- 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.