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

Hellenic Oncology Research Group

Status and phase

Terminated

Phase 3

Conditions

Breast Cancer

Treatments

Drug: Gemcitabine

Drug: Herceptin

Drug: Capecitabine (Xeloda)

Study type

Interventional

Funder types

Other

Identifiers

NCT00440622

CT/03.09

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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