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

Dexa Medica

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Treatments

Drug: DLBS1425

Study type

Interventional

Funder types

Industry

Identifiers

DLBS1425-0209

Details and patient eligibility

About

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

Enrollment

15 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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