NCT04250818

Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Texas Tech University Health Sciences Center, El Paso · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recent progress in immunotherapy (IT) has shifted treatment paradigms for multiple malignancies including breast cancer. It has been shown that levels of certain cytokines were correlated with increased response to immunotherapy in patients with metastatic breast cancer. In this study investigators will perform cytokine profiling among patients diagnosed with metastatic triple-negative breast cancer at different time points during the treatment.

Detailed description

This is a prospective study that has two groups of patients as determined by their prescribed treatment plan. Group A (control group) are patients with metastatic triple-negative breast cancer (TNBC) who receive chemotherapy only (current standard of care). Group B (experimental group) are patients with mTNBC who receive a combination of chemotherapy and IT immunotherapy (Atezolizumab) which is a standard of care for patients whose tumor express \>1% of PD-L1 molecules. T-cell cytokines will be measures prior to treatment and at multiple time points during the treatment.

Conditions

• Metastatic Triple-Negative Breast Cancer

Timeline

• Start date: 2019-07-02
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2020-01-31
• Last updated: 2021-05-19

Locations

1 site across 1 country: United States