Spots Global Cancer Trial Database for Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer
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Trial Identification
Brief Title: Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer
Official Title: A Phase II Study of Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer
Study ID: NCT00465673
Conditions
Interventions
Study Description
Brief Summary: 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
Detailed Description: 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
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Johns Hopkins Singapore International Medical Center, Singapore, , Singapore
Contact Details
Name: Alex Chang
Affiliation: Johns Hopkins SIngapore International Medical Center
Role: PRINCIPAL_INVESTIGATOR
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