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

NCT ID: NCT04250818

Last Updated: 2021-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-02

Study Completion Date

2021-05-31

Brief Summary

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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

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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.

Conditions

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Metastatic Triple-Negative Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

Patients with mTNBC who receive chemotherapy only

No interventions assigned to this group

Experimental Group

patients with mTNBC who receive a combination of chemotherapy and Immunotherapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role lead

Responsible Party

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Alexander Philipovskiy

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Texas Tech University HSC El Paso

El Paso, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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E19137

Identifier Type: -

Identifier Source: org_study_id

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