Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Female

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 breast cancer, combinations of either gemcitabine or capecitabine (Xeloda) plus Herceptin has been proved active and well tolerated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Capecitabine; Gemcitabine; Trastuzumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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