Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer

Inclusion Criteria:

* Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
* HER2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or FISH/CISH positivity. A score of 2+ by immunohistochemistry is acceptable only if FISH/CISH positive
* 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 (N0 with HER2/c-neu over expression are also eligible)
* 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%). Normal electrocardiogram and absence of significant heart disease
* 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.