Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Study Overview
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Brief Summary
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Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Official Title
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Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Specimen collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Ability to give informed consent Stage I-III breast malignancy Exclusion Criteria: Unable to tolerate venipuncture

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immediate Surgery<br>Adult patients with breast malignancy. | Other: Specimen collection<br>* Specimens are obtained from patients who are being treated for breast malignancies.<br>|
| Neo-adjuvant Chemotherapy<br>Adult patients with biopsy proven operable breast cancer who in the opinion of treating physician are suited to receive neo-adjuvant chemotherapy. | Other: Specimen collection<br>* Specimens are obtained from patients who are being treated for breast malignancies.<br>|
| Lymph Node Tissue<br>Adult patients with breast malignancy who will be having a primary lymph node removed during breast surgery. | Other: Specimen collection<br>* Specimens are obtained from patients who are being treated for breast malignancies.<br>|
| Metastatic Breast Cancer<br>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). | Other: Specimen collection<br>* Specimens are obtained from patients who are being treated for breast malignancies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Percentage of MDSC at baseline and whether there is an association of baseline MDSC percent with response to chemotherapy. | 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. | Changes will be reported in percentage of MDSC and associations of such changes with response to chemotherapy. | 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. | Isolate a lymph nodes from patients with breast cancer undergoing breast surgery to study what types of Natural Killer Cells are present. Natural Killer cells are immune cells that are capable of killing cancer cells. | up to 1 year |