Status:
COMPLETED
Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients
Lead Sponsor:
University Hospital of Crete
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
Epithelial tumor cells can be detected in the bone marrow and/or the peripheral blood \[disseminated and circulating tumor cells, (DTCs) and (CTCs) respectively\] of otherwise metastases-free patients...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00429247
Start Date
February 1 2003
End Date
December 1 2007
Last Update
July 21 2011
Active Locations (1)
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1
University Hospital of Crete
Heraklion, Crete, Greece, 71110