Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT04250818
Status:
SUSPENDED
Last Update Posted:
2021-05-19
First Post:
2019-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-06-15', 'releaseDate': '2021-05-20'}, {'resetDate': '2024-04-04', 'releaseDate': '2023-10-11'}], 'estimatedResultsFirstSubmitDate': '2021-05-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and whole blood cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI is moving to a new institution', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-17', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cytokine, breast cancer'], 'conditions': ['Metastatic Triple-Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women diagnosed with triple negative breast cancer', 'genderDescription': 'The majority of the patients with triple negative breast cancer are women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of metastatic triple negative breast cancer\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Younger than 18\n* Unwilling to participate or unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT04250818', 'briefTitle': 'Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University Health Sciences Center, El Paso'}, 'officialTitle': 'Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile', 'orgStudyIdInfo': {'id': 'E19137'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'Patients with mTNBC who receive chemotherapy only'}, {'label': 'Experimental Group', 'description': 'patients with mTNBC who receive a combination of chemotherapy and Immunotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University HSC El Paso', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University Health Sciences Center, El Paso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alexander Philipovskiy', 'investigatorAffiliation': 'Texas Tech University Health Sciences Center, El Paso'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-05-20', 'type': 'RELEASE'}, {'date': '2021-06-15', 'type': 'RESET'}, {'date': '2023-10-11', 'type': 'RELEASE'}, {'date': '2024-04-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Alexander Philipovskiy, Assistant Professor, Texas Tech University Health Sciences Center, El Paso'}}}}