Status:
TERMINATED
Study of Gemcitabine and Herceptin Versus Xeloda 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:
PHASE3
Brief Summary
The optimal treatment for pretreated patients with metastatic breast cancer has not been established. Gemcitabine and capecitabine are two active agents in this setting. For women with Her-2 positive ...
Detailed Description
This trial compares the efficacy of the combinations gemcitabine plus Herceptin versus capecitabine (Xeloda) plus Herceptin in pretreated patients with metastatic HER-2 positive breast cancer.
Eligibility Criteria
Inclusion
- Informed consent
- Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
- HER-2 overexpression 2+ or 3+ using IHC or FISH +
- Measurable disease
- At least one prior chemotherapy regimen
- Not in a prior irradiation field
- No patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
- No more than 25% of myeloproductive bone marrow irradiated. More than 4 weeks since prior radiotherapy and recovered
- Age 18 - 75 year old
- Performance status (WHO) 0-2
- Life expectancy more than 12 weeks
- Absolute neutrophil count \> 1500/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3)
- Adequate liver (bilirubin \< 2 mg/dL, SGOT/SGPT \< 2 times upper limit of normal, ALP \< 3 times upper limit of normal, creatinine \< 1.5 upper limit of normal
- Adequate cardiac function (LVEF \> 50%)
Exclusion
- Pregnant or nursing
- Positive pregnancy test
- Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
- Motor or sensory neuropathy \> grade 1 according to NCIC toxicity criteria
- 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 :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00440622
Start Date
April 1 2003
End Date
November 1 2008
Last Update
February 13 2013
Active Locations (9)
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1
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
2
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
3
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
4
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, Greece