Skip to content

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

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

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04250818
Enrollment
20
Registered
2020-01-31
Start date
2019-07-02
Completion date
2021-05-31
Last updated
2021-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Triple-Negative Breast Cancer

Keywords

cytokine, breast cancer

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.

Interventions

None listed

Sponsors

Texas Tech University Health Sciences Center, El Paso
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Progression free survival12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026