Status:
TERMINATED
Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in ...
Detailed Description
Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-pos...
Eligibility Criteria
Inclusion
- Performance status (WHO) 0-2
- Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
- HER-2 overexpression 2+ or 3+ using IHC or FISH +
- Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)
- No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)
- More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered
- No prior first line chemotherapy for metastatic disease
- Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease
- Paraffin block from the primary tumor available in the research lab
- 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 \< 2mg/dl)
- Adequate cardiac function (LVEF \> 50%)
- Informed consent
Exclusion
- Pregnant or nursing
- Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
- Positive pregnancy test
- Motor or sensory neuropathy \> grade 1 according to NCIC Τoxicity Criteria
- Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
- History of allergic reaction attributed to docetaxel
- Psychiatric illness or social situation that would preclude study compliance
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00453635
Start Date
December 1 2003
End Date
November 1 2008
Last Update
March 13 2012
Active Locations (10)
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1
University Hospital of Crete
Heraklion, Crete, Greece, 71110
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
4
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece