Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:

Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03244358
• Other study ID #: SYSUCC-010
• Status: Terminated
• Phase: Phase 2
• Start date: March 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Epalrestat
Epalrestat 50mg tid added to standard chemotherapy treatment

Locations

Country	Name	City	State
China	Sun Yat-sen University, Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	30 months
Secondary	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.	3 years