A Clinical Trial to Evaluate the Effects of Autologous induced Pluripotent Stem Cell-Derived Natural Killer Cells in Personalized Treatment of Patients with Advanced Metastatic Breast Cancer
Phase 1
- Conditions
- Advanced Breast Cancer.Malignant neoplasm of breast
- Registration Number
- IRCT20200429047241N1
- Lead Sponsor
- International Center for Personalized Medicine (ICPM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 32
Inclusion Criteria
Women with the diagnosis of ABC by any combination of ER, PR, and HER-2, who are progressed on chemotherapy and/or radiotherapy regimens for their metastatic disease.
Single metastasis patients with a measurable metastasis in the lymph node, lung, liver, and bone.
Women must be between 20 and 70 years of age.
Exclusion Criteria
Patients with active and uncontrolled infections.
Abnormal kidney, lung and liver function, measured by serum creatinine (serum creatinine> 2 mg / dl), saturated oxygen O2 = 96%) (Sat and liver enzymes (ALT / AST> 2.5 x N).
Patients with the other types of cancers unrelated to the primary breast tumors
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Probable toxicity resulting from Intervention. Timepoint: Pre- and post-intervention. Method of measurement: Physical examination, biochemical and serological tests, and electrocardiography.;Response to treatment. Timepoint: Pre- and post-intervention. Method of measurement: CT scan, histopathologic observations, and plasma level of tumor markers.;Progression-free survival. Timepoint: post-intervention. Method of measurement: Follow-up.;Immune system function. Timepoint: Pre- and post-intervention. Method of measurement: Flow cytometry and ELIZA cytokine assay.
- Secondary Outcome Measures
Name Time Method