Inclusion Criteria:

- Women with histologically-confirmed unilateral invasive ductal or lobular breast
adenocarcinoma

- Within 60 days after the surgical excision of the primary tumor with tumor-free
operation margins; at least 10 axillary lymph nodes have to be removed.

- Tumor involvement of at least one axillary lymph node

- Absence of any clinical or radiological evidence of local or metastatic disease

- Premenopausal or postmenopausal women aged 18-75 years old

- Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count
>100.000/mm3, hemoglobin >10gr/mm3)

- Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times
upper limit of normal) and renal function (creatinine <1.5mg/dl)

- Adequate cardiac function (LVEF>50%)

- Written informed consent

Exclusion Criteria:

- Positive pregnancy test.

- Psychiatric illness or social situation that would preclude study compliance.

- Other concurrent uncontrolled illness.

- Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy,
chemotherapy, biological agents.

- Previous history of other invasive malignancy other than non-melanomatous skin
cancer.