Advanced Breast Cancer. Malignant neoplasm of breast
Conditions
Interventions
Candidates besides their standard treatments receive a determined dosage of the generated NK cells (8-10 billion cell/m2) through three intravenous infusions courses..
Sponsors
International Center for Personalized Medicine (ICPM)
Eligibility
Sex/Gender
Female
Age
20 Years to 70 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamid Khodayari
Tehran University of Medical Sciences
Outcome results
None listed