Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to difficulty of find eligible subjects
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DLBS1425 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment I
- description
- DLBS1425 150 mg three times daily
- interventionNames
- Drug: DLBS1425
- type
- EXPERIMENTAL
- label
- Treatment II
- description
- DLBS1425 300 mg three times daily
- interventionNames
- Drug: DLBS1425
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available