Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT04250818
Status:
SUSPENDED
Last Update Posted:
2021-05-19
First Post:
2019-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile
Sponsor:
Texas Tech University Health Sciences Center, El Paso
Organization:
Study Overview
Official Title:
Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile
Status:
SUSPENDED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI is moving to a new institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: