Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile
- Conditions
- Metastatic Triple-Negative Breast Cancer
- Registration Number
- NCT04250818
- Lead Sponsor
- Texas Tech University Health Sciences Center, El Paso
- Brief 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 20
- Diagnosis of metastatic triple negative breast cancer
- 18 years of age or older
- Younger than 18
- Unwilling to participate or unable to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Texas Tech University HSC El Paso
🇺🇸El Paso, Texas, United States
Texas Tech University HSC El Paso🇺🇸El Paso, Texas, United States