Clinical trial · Interventional
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study
NCT03244358CI-TRIAL-00049722terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty accruing subjects the study accrual was closed
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple negative breast
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 |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epalrestat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epalrestat
- description
- Epalrestat added to standard treatment
- interventionNames
- Drug: Epalrestat
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- 30 months
- description
- the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
Secondary outcomes (2)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- 30 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female ≥ 18 years, ≤70 years. * Minimum life expectancy 16 weeks * Histologicalconfirmation of hormone receptor negative and HER2 negative breast cancer(IHC:ER -, PR-) on primary tumour at diagnosis/on biopsy of metastasis * Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection * ECOG 0-2 with no deterioration over previous 2 weeks Measurable disease * Adequate bone marrow and organ function * Availability of archival tumour sample or fresh biopsy Informed consent * Normal organ function Exclusion Criteria: * Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation \<21 days prior to study treatment * Last dose of palliative radiotherapy \<7 days prior to study treatment * Rapidly progressive visceral disease not suitable for further therapy * Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for ≥ 4 weeks study treatment * Major surgery (excluding placement of vascular access) within 4 weeks before study treatment * Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV * With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment * Elevated ALP in absence of bone metastasis * Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent * Participation in another study with investigational product during last 30 days * Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
References
Publications (0)
Data not yet available
No reference posted for this study.