Back to resultsEvaluation of Epalrestat in Metastatic Triple-negative Breast Cancer
Primary Purpose
Triple Negative Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Epalrestat
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Triple Negative Breast Cancer, Epalrestat
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
Sites / Locations
- Sun Yat-sen University, Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epalrestat
Arm Description
Epalrestat added to standard treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall Survival
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03244358
Brief Title
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer
Official Title
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficulty accruing subjects the study accrual was closed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
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
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
Keywords
Triple Negative Breast Cancer, Epalrestat
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epalrestat
Arm Type
Experimental
Arm Description
Epalrestat added to standard treatment
Intervention Type
Drug
Intervention Name(s)
Epalrestat
Other Intervention Name(s)
Tanglin (Yangtze River Pharmaceutical Group), China
Intervention Description
Epalrestat 50mg tid added to standard chemotherapy treatment
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
30 months
Title
Overall Survival
Description
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.
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhongyu yuan, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University, Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer
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