Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer

Phase 2

Terminated

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: Epalrestat

• Registration Number: NCT03244358
• Lead Sponsor: Sun Yat-sen University

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).

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-09
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epalrestat	Epalrestat	Epalrestat added to standard treatment

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	30 months	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

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	30 months	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall Survival	3 years	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.

Trial Locations

Locations (1)

Sun Yat-sen University, Cancer Center; 🇨🇳 Guangzhou, Guangdong, China