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

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

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

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