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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250818
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Alexander Philipovskiy, Texas Tech University Health Sciences Center, El Paso

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Metastatic Triple-Negative Breast Cancer

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
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Study Type : Observational
Estimated 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 : July 2, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort
Control Group
Patients with mTNBC who receive chemotherapy only
Experimental Group
patients with mTNBC who receive a combination of chemotherapy and Immunotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Serum and whole blood cells

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The majority of the patients with triple negative breast cancer are women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women diagnosed with triple negative breast cancer
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250818


Contacts
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Contact: Alexander Philipovskiy, MD, PhD 915-215-5195 alexander.philipovskiy@ttuhsc.edu
Contact: Brenda Castillo 915-215-4831 brenda.castillo@ttuhsc.edu

Locations
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United States, Texas
Texas Tech University HSC El Paso Recruiting
El Paso, Texas, United States, 79905
Contact: Alexander Philipovskiy, MD, PhD    915-215-5195    alexander.philipovskiy@ttuhsc.edu   
Contact: Brenda Castillo, BS    915-215-4831    brenda.castillo@ttuhsc.edu   
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
More Information
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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: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexander Philipovskiy, Texas Tech University Health Sciences Center, El Paso:
cytokine, breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases