Clinical trial NCT01006785: Efficacy and Safety of DLBS1425 in Subjects With Advanced/Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
DLBS 1425
Cancer
Advanced/Metastatic (Stage IIIB/IV) Breast Cancer
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2009-11-03
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12 -16 weeks
Secondary outcomes:
measure: Time point overall response rate
timeFrame: 6 weeks
measure: Routine hematology
timeFrame: at interval of 2 weeks over the 12 -16 weeks of treatment
measure: Liver function
timeFrame: at interval of 2 weeks over the 12 -16 weeks of treatment
measure: Renal function
timeFrame: at interval of 2 weeks over the 12 -16 weeks of treatment
measure: ECHO
timeFrame: at baseline and at week 6, 12, and 16 of treatment
measure: Adverse events
timeFrame: during 12 - 16 weeks of treatment
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Dr. Sardjito Hospital, Department of Internal Medicine
state: DI Yogyakarta
city: Jakarta
country: Indonesia
facility: Dr. Cipto Mangunkusumo Hospital, Division of Medical Haematology and Oncology
state: DKI Jakarta
city: Bandung
country: Indonesia
facility: Dr. Hasan Sadikin Hospital, Department of Internal Medicine
state: West Java
Study officials:
affiliation: Division of Medical Haematology and Oncology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital
name: Abdul Muthalib, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: