The purposes of this study are : * to investigate the safety and clinical efficacy of sole therapy with DLBS1425 in suppressing disease-(tumour) progression in subjects with advanced/metastatic breast cancer; and * to determine the minimal effective and safe dose of DLBS1425 in the therapy of advanced/metastatic breast cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Dr. Sardjito Hospital, Department of Internal Medicine
Yogyakarta, DI Yogyakarta, Indonesia
Dr. Cipto Mangunkusumo Hospital, Division of Medical Haematology and Oncology
Jakarta, DKI Jakarta, Indonesia
Dr. Hasan Sadikin Hospital, Department of Internal Medicine
Bandung, West Java, Indonesia
Best overall response rate: proportion of subjects with either complete or partial response according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria at the end of study
Time frame: 12 -16 weeks
Time point overall response rate
Time frame: 6 weeks
Routine hematology
Routine hematology including hemoglobin, hematocrit, red blood cells, white blood cells, differentiation of WBC, and platelet count
Time frame: at interval of 2 weeks over the 12 -16 weeks of treatment
Liver function
Liver function including alkaline phosphatase, serum ALT, serum AST, and bilirubin
Time frame: at interval of 2 weeks over the 12 -16 weeks of treatment
Renal function
Renal function including serum creatinine
Time frame: at interval of 2 weeks over the 12 -16 weeks of treatment
ECHO
Time frame: at baseline and at week 6, 12, and 16 of treatment
Adverse events
Time frame: during 12 - 16 weeks of treatment
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