Breast Cancer Clinical Trial
Official title:
A Phase II Study of Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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