- Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not
amenable to surgery, radiation, or combined modality therapy with curative intent
- Measurable disease as per RECIST. Measurable lesions that have been previously
irradiated will not be considered target lesions unless increase in size has been
observed following completion of radiation therapy.
- Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or
metastatic disease settings.
- Histology of inflammatory carcinoma with no other measurable disease. Patients with
histology of inflammatory carcinoma are allowed on study if they have measurable
disease.
- Brain metastases, spinal cord compression, or carcinomatous meningitis, or
leptomeningeal disease.
- Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon
(5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1
(tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting