Clinical trial · Interventional
Efficacy and Safety of DLBS1425 as Neoadjuvant in Stage II or III Breast Cancer Patients
Combination of DLBS1425 With Anthracyclin-based Regimen as a Neoadjuvant Therapy in Subjects With Stage II or III Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a 2-arm, randomized, double-blind, placebo-controlled study aiming to determine the efficacy and safety of DLBS1425 in combination with anthracyclin-based regimen as a neoadjuvant therapy in subjects with previously untreated stage II or III (operable) breast cancer. The anthracyclin-based regimen in the study will be either CAF/iv and CEF/iv only. The neoadjuvant anthracyclin-based chemotherapy will be given for 3 cycles. The length of each cycle will be 21-28 days.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DLBS1425 | Drug | — | UNRESOLVED |
| Placebo DLBS1425 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DLBS1425
- interventionNames
- Drug: DLBS1425
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo DLBS1425
Primary outcomes (1)
- measure
- Clinical response as measured by RECIST
- timeFrame
- 63 - 84 days
- description
- Best overall response rate defined as proportion of subjects with either complete or partial response, according to the RECIST criteria at the end of study.
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed stage II or III (operable) primary breast cancer * Having radiologically evaluable and measurable lesion(s) of the primary tumor * Karnofsky performance status 80 % * Normal cardiac function: LVEF \> 50 % * Adequate hematological function: Hb ≥ 10.0 g/dL, WBC ≥ 3,000/mm3, ANC ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3 * Adequate liver function: ALT ≤ 2.5 times upper limit of normal, total bilirubin level ≤ 1.5 times upper limit of normal * Adequate renal function: serum creatinine ≤ 1.5 times upper limit of normal * Able to take oral medication Exclusion Criteria: * Pregnancy or breast feeding subjects * History of previous breast cancer (recurrent breast cancer) * History of other cancer within the past 5 years * Prior systemic treatment for the current breast cancer * Prior preoperative topical treatments for the current breast cancer * Uncontrolled or serious CVD * Known or suspected hypersensitivity to any of the chemotherapeutic agents used in the study * Any other serious disease state or medical condition which judged by investigator could interfere with trial participation or trial evaluation * Concurrent herbal (alternative) medicines or food supplements suspected to have effect on breast cancer disease within 14 days prior to screening * Severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent * Participation in any other clinical studies within 30 days prior to screening
References
Publications (0)
Data not yet available