NCT03244358

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

3.8 years

First QC Date

July 23, 2017

Last Update Submit

January 26, 2021

Conditions

Triple Negative Breast Cancer

Keywords

Triple Negative Breast CancerEpalrestat

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    30 months

  • Overall Survival

    3 years

Study Arms (1)

Epalrestat

EXPERIMENTAL

Epalrestat added to standard treatment

Drug: Epalrestat

Interventions

EpalrestatDRUG

Epalrestat 50mg tid added to standard chemotherapy treatment

Also known as: Tanglin (Yangtze River Pharmaceutical Group), China
Epalrestat

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

epalrestat

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • zhongyu yuan, M.D.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professer

Study Record Dates

First Submitted

July 23, 2017

First Posted

August 9, 2017

Study Start

March 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 29, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)