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

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: DLBS1425

• Registration Number: NCT01006785
• Lead Sponsor: Dexa Medica Group

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-11-01
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-17
• Last Update Posted: 2012-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment II	DLBS1425	DLBS1425 300 mg three times daily
Treatment I	DLBS1425	DLBS1425 150 mg three times daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time point overall response rate	6 weeks
Routine hematology	at interval of 2 weeks over the 12 -16 weeks of treatment	Routine hematology including hemoglobin, hematocrit, red blood cells, white blood cells, differentiation of WBC, and platelet count
Liver function	at interval of 2 weeks over the 12 -16 weeks of treatment	Liver function including alkaline phosphatase, serum ALT, serum AST, and bilirubin
Renal function	at interval of 2 weeks over the 12 -16 weeks of treatment	Renal function including serum creatinine
ECHO	at baseline and at week 6, 12, and 16 of treatment
Adverse events	during 12 - 16 weeks of treatment

Trial Locations

Locations (3)

Dr. Cipto Mangunkusumo Hospital, Division of Medical Haematology and Oncology; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

Dr. Hasan Sadikin Hospital, Department of Internal Medicine; 🇮🇩 Bandung, West Java, Indonesia

Dr. Sardjito Hospital, Department of Internal Medicine; 🇮🇩 Yogyakarta, DI Yogyakarta, Indonesia