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Keep this study
Lead
Hellenic Oncology Research Group
With
University Hospital of Crete
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.
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
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%)
You may not be if
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
Clareo Health | Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
