Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

• Overall survival between the two treatment arms
• Toxicity profile between the two treatment arms

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.

• Drug: Gemcitabine
  Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles
  Other Name: Gemzar
• Drug: Capecitabine
  Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles
  Other Name: Xeloda
• Drug: Vinorelbine
  Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles
  Other Name: Navelbine

• Active Comparator: 1
  Vinorelbine/Gemcitabine (VG)
  Interventions:

  • Drug: Gemcitabine
  • Drug: Vinorelbine
• Active Comparator: 2
  Capecitabine (Cap)
  Intervention: Drug: Capecitabine

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.