Primary objective: To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis Secondary objectives: 1. To determine the overall objective response rate (ORR) 2. To determine the progression free survival, and duration of objective response 3. To evaluate the overall survival (OS) 4. To assess the safety profiles
This is an open-label, non-comparative phase II clinical trial. Approximately thirty-three patients will be enrolled in order to obtain twenty-nine evaluable subjects who received two cycles of study treatment in Simon's 2-stage optimal design. Duration of subject involvement: Study treatment should be administered up to disease progression, intolerable toxicity, or consent withdrawal. Recruitment period: 10 months
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
40mg/m2 over 1 hour infusion for 21 days
Johns Hopkins Singapore International Medical Center
Singapore, Singapore
Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
Time frame: 3 years
To determine the overall objective response rate
Time frame: 3 years
To determine the progression free survival, and duration of objective response
Time frame: 3 years
To evaluate the overall survival
Time frame: 3 years
To assess the safety profiles
Time frame: 3 years
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