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

Sponsor
Texas Tech University Health Sciences Center, El Paso (Other)
Overall Status
Suspended
CT.gov ID
NCT04250818
Collaborator
(none)
20
Enrollment
1
Location
22
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile
    Actual Study Start Date :
    Jul 2, 2019
    Anticipated Primary Completion Date :
    May 1, 2021
    Anticipated Study Completion Date :
    May 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Control Group

    Patients with mTNBC who receive chemotherapy only
    Experimental Group

    patients with mTNBC who receive a combination of chemotherapy and Immunotherapy

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Texas Tech University HSC El Paso El Paso Texas United States 79905

    Sponsors and Collaborators

    • Texas Tech University Health Sciences Center, El Paso

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alexander Philipovskiy, Assistant Professor, Texas Tech University Health Sciences Center, El Paso
    ClinicalTrials.gov Identifier:
    NCT04250818
    Other Study ID Numbers:
    • E19137
    First Posted:
    Jan 31, 2020
    Last Update Posted:
    May 19, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alexander Philipovskiy, Assistant Professor, Texas Tech University Health Sciences Center, El Paso
    cytokine, breast cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Triple Negative Breast Neoplasms

    Study Results

    No Results Posted as of May 19, 2021