Triple Negative Breast Cancer
Conditions
Keywords
Triple Negative Breast Cancer, Epalrestat
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).
Interventions
DRUGEpalrestat
Epalrestat 50mg tid added to standard chemotherapy treatment
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
China
Outcome results
None listed