Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: docetaxel and capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel and capecitabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall clinical benefit rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability |  |  | 
| evaluate QOL |  |  | 
| determine progression free survival |  |  | 
| determine time to response and overall survival |  |  |