Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer

Sun Yat-sen University

Status and phase

Terminated

Phase 2

Conditions

Triple Negative Breast Cancer

Treatments

Drug: Epalrestat

Study type

Interventional

Funder types

Other

Identifiers

NCT03244358

SYSUCC-010

Details and patient eligibility

About

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

Full 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.Primary endpoint is 16-week clinical benefit rate (CBR).

Enrollment

12 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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