Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer

NCT ID: NCT03244358

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2020-12-01

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

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epalrestat

Epalrestat added to standard treatment

Group Type: EXPERIMENTAL

Epalrestat

Intervention Type: DRUG

Epalrestat 50mg tid added to standard chemotherapy treatment

Interventions

Epalrestat

Epalrestat 50mg tid added to standard chemotherapy treatment

Intervention Type: DRUG

Other Intervention Names

Tanglin (Yangtze River Pharmaceutical Group), China

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhong-yu Yuan

professer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhongyu yuan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SYSUCC-010

Identifier Type: -

Identifier Source: org_study_id