Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer

• Status: Terminated
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple negative breast

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Epalrestat

Criteria

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