Three Doses of TAS-108 to Treat Recurrent or Recurrent Inoperable Breast Cancer

Inclusion Criteria

• •Postmenopausal females
• •Histologically or cytologically confirmed diagnosis of breast carcinoma
• •Locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression
• •Has laboratory documentation of positive estrogen receptor (ER) and/or progesterone receptor (PgR) status, and has responded to the standard first or second line hormonal anti-tumor therapy given
• •Has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies
• •Performance status of greater than or equal to 2 on the Zubrod scale
• •Predicted life expectancy of greater than or equal to 12 weeks
• •Must give written informed consent
• •Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• •Absolute granulocyte count of greater than 1,500/meqL, platelet count greater than 75,000/meqL, and a hemoglobin of greater than 10 g/dL
• •Adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal
• •Transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal.
• •The patient has recovered from all previous anti-cancer treatment related to toxicities to at least Grade 1.
• •All previous investigational drugs must be stopped at least four weeks before commencement of treatment with TAS-108.