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Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer

Sponsor
Sun Yat-sen University (Other)
Overall Status
Terminated
CT.gov ID
NCT03244358
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
45
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Epalrestat

Epalrestat added to standard treatment

Drug: Epalrestat
Epalrestat 50mg tid added to standard chemotherapy treatment
Other Names:
  • Tanglin (Yangtze River Pharmaceutical Group), China

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University, Cancer Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: zhongyu yuan, M.D., Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhong-yu Yuan, professer, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT03244358
    Other Study ID Numbers:
    • SYSUCC-010
    First Posted:
    Aug 9, 2017
    Last Update Posted:
    Jan 29, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Zhong-yu Yuan, professer, Sun Yat-sen University
    Triple Negative Breast Cancer
    Epalrestat
    Additional relevant MeSH terms:
    Breast Neoplasms
    Triple Negative Breast Neoplasms
    Epalrestat

    Study Results

    No Results Posted as of Jan 29, 2021