Efficacy and Safety of DLBS1425 in Subjects With Advanced/Metastatic Breast Cancer

Study Overview
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Brief Summary
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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

Official Title
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Phase II Clinical Study: A Randomized, Open, and Dose Ranging Study to Evaluate the Efficacy and Safety of DLBS1425 in Subjects With Metastatic / Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: DLBS1425
* Drug: DLBS1425


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment I<br>DLBS1425 150 mg three times daily | Drug: DLBS1425<br>* 3 X 150 mg daily for 12 - 16 weeks of treatment<br>|
| Experimental: Treatment II<br>DLBS1425 300 mg three times daily | Drug: DLBS1425<br>* 3 X 300 mg daily for 12 - 16 weeks of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time point overall response rate |  | 6 weeks | 
| Routine hematology | Routine hematology including hemoglobin, hematocrit, red blood cells, white blood cells, differentiation of WBC, and platelet count | 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 | at interval of 2 weeks over the 12 -16 weeks of treatment | 
| Renal function | Renal function including serum creatinine | at interval of 2 weeks over the 12 -16 weeks of treatment | 
| ECHO |  | at baseline and at week 6, 12, and 16 of treatment | 
| Adverse events |  | during 12 - 16 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, DLBS 1425, Cancer, Advanced/Metastatic (Stage IIIB/IV) Breast Cancer