Breast Cancer
Conditions
Keywords
Breast Cancer, DLBS 1425, Cancer, Advanced/Metastatic (Stage IIIB/IV) Breast Cancer
Brief summary
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
Interventions
DRUGDLBS1425
3 X 150 mg daily for 12 - 16 weeks of treatment
Sponsors
Dexa Medica Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects diagnosed with Stage IIIB or IV breast cancer who have failed with or refuse to receive standard chemotherapies * Subjects with the expression of ER/PR negative; or positive ER/PR expression but have failed with or refuse to receive hormonal therapy * Either + or - expression of HER-2/neu gene * ECOG status = 0-2 * At least have 1 evaluable and measurable metastatic lesion as defined by RECIST criteria * Adequate haematological, liver, and renal function * At least 3 weeks has elapsed since prior chemotherapy, radiotherapy, biological/hormonal therapy * At least 4 weeks has elapsed since surgical biopsy / major surgery
Exclusion criteria
* Allergic to the trial product * Any other disease state, including infections or uncontrolled illnesses that could interfere with trial participation or trial evaluation * Concurrent herbal (alternative) medicine or food supplements suspected to have effect on cancer disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 12 -16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Routine hematology | at interval of 2 weeks over the 12 -16 weeks of treatment | Routine hematology including hemoglobin, hematocrit, red blood cells, white blood cells, differentiation of WBC, and platelet count |
| Liver function | at interval of 2 weeks over the 12 -16 weeks of treatment | Liver function including alkaline phosphatase, serum ALT, serum AST, and bilirubin |
| Time point overall response rate | 6 weeks | — |
| ECHO | at baseline and at week 6, 12, and 16 of treatment | — |
| Adverse events | during 12 - 16 weeks of treatment | — |
| Renal function | at interval of 2 weeks over the 12 -16 weeks of treatment | Renal function including serum creatinine |
Countries
Indonesia
Outcome results
None listed