Metastatic Breast Cancer
Conditions
Brief summary
In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.
Interventions
Sponsors
Oncology Specialties, Alabama
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall clinical benefit rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability | — |
| evaluate QOL | — |
| determine progression free survival | — |
| determine time to response and overall survival | — |
Countries
United States
Outcome results
None listed