Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

A Multicenter Randomized Phase III Study of Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline

The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. Whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.

This trial will compare the efficacy of combination treatment with Vinorelbine and Gemcitabine versus Capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline.

Inclusion Criteria:

• Age 19-75 years.
• Performance status World Health Organization (WHO) 0-2.
• Histologically confirmed breast adenocarcinoma.
• Clinical or radiological evidence of metastatic disease that has progressed after combination treatment of a taxane and an anthracycline (Taxotere + Mitoxantrone or Taxotere + Farmorubicine).
• Measurable disease.
• No metastatic central nervous system (CNS) disease.
• Less than 25% of myeloproductive bone marrow irradiated.
• 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 < 2 mg/dl).
• Informed consent.

Exclusion Criteria:

• Pregnancy or nursing.
• Positive pregnancy test.
• Psychiatric illness or social situation that would preclude study compliance.
• Other concurrent uncontrolled illness.
• Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.