Clinical trial NCT03244358: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Keywords: Triple Negative Breast Cancer
Epalrestat
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 30 months
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 30 months
measure: Overall Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University, Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: zhongyu yuan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: