Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date December 18, 2019
First Posted Date January 31, 2020
Last Update Posted Date January 31, 2020
Actual Study Start Date July 2, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2020)
Progression free survival [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile
Official Title Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum and whole blood cells
Sampling Method Non-Probability Sample
Study Population Women diagnosed with triple negative breast cancer
Condition Metastatic Triple-Negative Breast Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Control Group
    Patients with mTNBC who receive chemotherapy only
  • Experimental Group
    patients with mTNBC who receive a combination of chemotherapy and Immunotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 29, 2020)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: The majority of the patients with triple negative breast cancer are women
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Alexander Philipovskiy, MD, PhD 915-215-5195 alexander.philipovskiy@ttuhsc.edu
Contact: Brenda Castillo 915-215-4831 brenda.castillo@ttuhsc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04250818
Other Study ID Numbers E19137
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Alexander Philipovskiy, Texas Tech University Health Sciences Center, El Paso
Study Sponsor Texas Tech University Health Sciences Center, El Paso
Collaborators Not Provided
Investigators Not Provided
PRS Account Texas Tech University Health Sciences Center, El Paso
Verification Date January 2020