Refractory breast cancer.
Conditions
Interventions
Autologous NK enriched immune cells injection into the patients every 2 weeks during 3 months.
Sponsors
VC for Research and Technology and Institute for stem cells and regenerative medicine, Shiraz Unive
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patients with breast cancer, Infiltrative Ductal Carcinoma (IDC) Patients with end stage breast cancer (Stage 4) Patients with refractory breast cancer based on National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) guidelines Triple negative (ER-,PR- and Her2-) breast cancer patients Patients with the minimum age of 18 years old and maximum 60 years old Performance status =0 or 1 Life expectancy for patients: more than 3 months
Exclusion criteria
Exclusion criteria: Patients with autoimmune disease Patients with active infection Patients who spend the intensive radiotherapy Pregnant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining how well NK enriched immune cells can be tolerated in patients. Safety and toxicity will be determined based on Common Terminology Criteria for Adverse Events (CTCAEs) guideline. Timepoint: The period between the first injection and 2 months after the last injection. Method of measurement: According to the CTCAEs [Common Terminology Criteria for Adverse Events]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological responses in the patients. Timepoint: The period between the first injection and 2 months after the last injection. Method of measurement: The flowcytometeric analysis of different immune cells percentage including B, T (CD4+ and CD8+), NK subsets, CD4+ regulatory T cells in PBMCs isolated from the patients. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSomayeh Rezaeifard
Shiraz University of Medical Sciences, Medical School, Shiraz Institute for Cancer Research
Outcome results
None listed