Recruiting

Observational Study

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT04022616

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Specimen collection

Study Details

Brief summary:

Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Conditions

Breast Cancer

Study ID

NCT04022616

Start date

Jun 4, 2010

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

99 participants

Anticipated

Interventions and Outcome Measures

Arms

Immediate Surgery

Adult patients with breast malignancy.

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.

Lymph Node Tissue

Adult patients with breast malignancy who will be having a primary lymph node removed during breast surgery.

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).

Interventions

Specimen collection

Specimens are obtained from patients who are being treated for breast malignancies.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ohio State Comprehensive Cancer Center

1-800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-04-06.