Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer

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