Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple negative breast

Detailed Description
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This is a phase II,single center,prospective, single arm clinical trials. The objective is to evaluate the efficacy and safetyof Epalrestat in the treatment of metastatic triple negative breast.Primary endpoint is 16-week clinical benefit rate (CBR).

Official Title
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Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: Epalrestat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epalrestat<br>Epalrestat added to standard treatment | Drug: Epalrestat<br>* Epalrestat 50mg tid added to standard chemotherapy treatment<br>* Other names: Tanglin (Yangtze River Pharmaceutical Group), China;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | 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 | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 30 months | 
| Overall Survival | OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triple Negative Breast Cancer, Epalrestat