The purpose of this study is to evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).
Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase IV study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of Genexol-PM in patients with Taxane-pretreated recurrence breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Genexol-PM at a dose of 300mg/m2 was diluted in 500 ml of 5% dextrose solution or normal saline and infused i.v. for 3 h on day 1.Treatment was repeated every 3 weeks until either disease progression or intolerance. A minimum of 6 cycles was recommended.
Department of surgery, The Catholoic university of Korea, St. Mary's hospital.
Seoul, South Korea
Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
Time frame: 1 year
Toxicity
Time frame: 1 year
Progression Free Survival
Time frame: 1 year
Tumor control rate
Time frame: 1 year
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