Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Isolate unfavorable immune cells MDSC from the peripheral blood or tumors of study subjects and test how strongly they inhibit function of favorable immune cells called Natural Killer Cells.
Study Overview
Brief Summary
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •Ability to give informed consent
- •Stage I-III breast malignancy
Exclusion Criteria
- •Unable to tolerate venipuncture
Arms & Interventions
Immediate Surgery
Adult patients with breast malignancy.
Intervention: Specimen collection (Other)
Neo-adjuvant Chemotherapy
Adult patients with biopsy proven operable breast cancer who in the opinion of treating physician are suited to receive neo-adjuvant chemotherapy.
Intervention: Specimen collection (Other)
Lymph Node Tissue
Adult patients with breast malignancy who will be having a primary lymph node removed during breast surgery.
Intervention: Specimen collection (Other)
Metastatic Breast Cancer
Adult patients with biopsy proven stage IV breast cancer who are starting a new line palliative systemic therapy. A palliative systemic therapy will be defined in this trial as any chemotherapy regimen or combination of endocrine therapy with targeted agents such as cyclin dependent kinase 4/6 (CDK 4/6) inhibitors, HER2 targeting agents or inhibitors of mammalian target of rapamycin (mTOR).
Intervention: Specimen collection (Other)
Outcomes
Primary Outcomes
Isolate unfavorable immune cells MDSC from the peripheral blood or tumors of study subjects and test how strongly they inhibit function of favorable immune cells called Natural Killer Cells.
Time Frame: up to 1 year
Function of Natural Killer Cells will be studied by measuring their ability to kill target cancer cells coated with monoclonal antibodies. isolate unfavorable immune cells called Myeloid Derived Suppressor Cells (MDSC) from the peripheral blood or the tumors of study subjects and test how strongly they inhibit function of favorable immune cells called Natural Killer Cells. Function of Natural Killer Cells will be studied by measuring their ability to kill target cancer cells coated with monoclonal antibodies.
Secondary Outcomes
- Isolate unfavorable immune cells called Myeloid Derived Suppressor Cells (MDSC) from the peripheral blood of study subjects who plan to start pre-operative chemotherapy for breast cancer to see if MDSC levels can predict who will respond to treatment. W(up to 1 year)
- Isolate lymph nodes from patients with breast cancer undergoing breast surgery to study what types of Natural Killer Cells are present.(up to 1 year)
- Isolate unfavorable immune cells MDSC from peripheral blood of study subjects who receive pre-operative chemotherapy for breast cancer to identify changes in MDSC levels during treatment can predict who will respond to treatment.(up to 1 year)
Investigators
William Carson
Principal Investigator
Ohio State University Comprehensive Cancer Center