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

Metastatic Triple-Negative Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04250818
• Other study ID #: E19137
• Status: Suspended
• Start date: July 2, 2019
• Est. completion date: May 2021

Study information

• Verified date: May 2021
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Triple-Negative Breast Cancer
• Triple Negative Breast Neoplasms

Locations

Country	Name	City	State
United States	Texas Tech University HSC El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		12 months