Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients

Inclusion Criteria

• •Age \>= 18 years.
• •Performance status (World Health Organization \[WHO\]) \< 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 (left ventricular ejection fraction \[LVEF\] \> 50%).
• •Informed consent
• •Histologically or cytologically confirmed breast adenocarcinoma
• •Prior surgical excision of the primary breast tumor
• •Prior completion of standard adjuvant chemotherapy and/or radiotherapy
• •Locally advanced disease after the completion of neo-adjuvant chemotherapy, surgical excision and radiotherapy provided that there was no evidence of local or metastatic disease
• •Absence of any clinical or laboratory evidence of metastatic disease
• •Detection of CTCs and/or DTCs (when it could be feasible) before the initiation and/or after the completion of adjuvant chemotherapy and/or radiotherapy
• •Expression of HER2/c-neu on the primary tumor is not mandatory