Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
Inclusion Criteria:
- must have metastatic breast cancer
- must have cytologically or pathologically confirmed invasive ductal or lobular
carcinoma
- must have measurable or evaluable disease
- ECOG of 0-1
- patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer
- must have adequate organ function
- must be at least 19 years of age
- peripheral neuropathy less than or equal to grade 1
- must have voluntarily signed informed consent
- patients with brain metastases are eligible provided that other measurable disease
exists and brain lesions are controlled
Exclusion Criteria:
- patients with other malignancies, except non melanoma of the skin, who have had any
evidence of cancer within the last 5 years
- patients with psychiatric illness or other concurrent severe co-morbid medical
condition that would preclude study completion
- known uncontrolled existing coagulopathy
- patients with a history of severe hypersensitivity reaction to docetaxel, medications
formulated with polysorbate 80 or 5-fluorouracil
- use of other investigational agents in the last 28 days
- pregnant or lactating women
- patients who are known HIV positive
- patients with life expectancy of less than 3 months
- sexually active patients unwilling to practice reliable contraception during the
study