Status:
TERMINATED
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple negative breast
Detailed Description
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.Primar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03244358
Start Date
March 1 2017
End Date
December 1 2020
Last Update
January 29 2021
Active Locations (1)
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1
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China, 510060