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

Texas Tech University Health Sciences Center, El Paso

Status: Suspended

Conditions: Metastatic Triple-Negative Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04250818

E19137

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of metastatic triple negative breast cancer
• 18 years of age or older

Exclusion criteria

• Younger than 18
• Unwilling to participate or unable to give informed consent

Trial design

20 participants in 2 patient groups

Control Group

Description:

Patients with mTNBC who receive chemotherapy only

Experimental Group

Description:

patients with mTNBC who receive a combination of chemotherapy and Immunotherapy