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Keep this study
Lead
University Hospital of Crete
This pilot trial will compare the efficacy of the anti-HER2/erb-B2 monoclonal antibody trastuzumab (HERCEPTIN) given after the completion of the standard adjuvant chemotherapy and radiotherapy versus observation in patients with stage I-III operable breast cancer who have detectable cytokeratin-19 (CK-19) mRNA-positive tumor cells in the bone marrow or the peripheral blood before and/or after the adjuvant treatment.
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Other concurrent uncontrolled illness
Psychiatric illness or social situation that would preclude study compliance
Pregnant or nursing
Positive pregnancy test
History of allergic reaction attributed to trastuzumab (HERCEPTIN)
Clareo Health | Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients
