Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile
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| ClinicalTrials.gov Identifier: NCT04250818 |
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Recruitment Status :
Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
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Sponsor:
Texas Tech University Health Sciences Center, El Paso
Information provided by (Responsible Party):
Alexander Philipovskiy, Texas Tech University Health Sciences Center, El Paso
| Tracking Information | |||||||||
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| 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 |
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 |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Serum and whole blood cells
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| 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 |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| 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 | ||||||||