Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: Specimen collection

• Registration Number: NCT04022616
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-04
• Study First Submitted: 2019-06-15
• Study First Submitted QC: 2019-07-13
• Study First Posted: 2019-07-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

• 18 years of age or older
• Ability to give informed consent
• Stage I-III breast malignancy

Exclusion Criteria

• Unable to tolerate venipuncture

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lymph Node Tissue	Specimen collection	Adult patients with breast malignancy who will be having a primary lymph node removed during breast surgery.
Metastatic Breast Cancer	Specimen collection	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).
Immediate Surgery	Specimen collection	Adult patients with breast malignancy.
Neo-adjuvant Chemotherapy	Specimen collection	Adult patients with biopsy proven operable breast cancer who in the opinion of treating physician are suited to receive neo-adjuvant chemotherapy.

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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	Percentage of MDSC at baseline and whether there is an association of baseline MDSC percent with response to chemotherapy.
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 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.
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	Changes will be reported in percentage of MDSC and associations of such changes with response to chemotherapy.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States