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

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group

Criteria

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