Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-03-06 @ 3:02 AM
Study NCT ID:
NCT05396612
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2022-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of the Immune Environment in Response to Therapy in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative 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': 'Tissue from breast tumors removed as standard of care treatment for breast cancer.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-05-25', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collecting, processing and archiving breast cancer tumor tissues', 'timeFrame': 'Through study completion, average of 2 years', 'description': 'This study will collect and analyze tumor samples from women diagnosed with primary breast cancer. The investigators will dissociate fresh tumor samples and analyze single cell suspensions by flow cytometry. Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between breast cancer subtypes (HR+HER2-, HER2+, triple negative). Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between HR+HER2- untreated breast cancers compared to HR+HER2- chemotherapy treated breast cancers.'}], 'secondaryOutcomes': [{'measure': 'Associating breast cancer dendritic cell infiltrate with outcome', 'timeFrame': '5 years', 'description': 'We will perform studies to associate dendritic cell infiltration and activation markers with patient outcome, including disease free survival, distant disease free survival, and overall survival.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune microenvironment'], 'conditions': ['Breast Cancer', 'ER Positive Breast Cancer', 'HER2-negative Breast Cancer', 'TNBC - Triple-Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women 18 years of age or older undergoing surgery for breast cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nWomen 18 years of age or older with non-metastatic breast cancer undergoing surgical resection in the University of Pennsylvania Health System.\n\nExclusion criteria:\n\nMales Children Pregnant individuals'}, 'identificationModule': {'nctId': 'NCT05396612', 'briefTitle': 'Role of the Immune Environment in Response to Therapy in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Role of the Immune Environment in Response to Therapy in Breast Cancer', 'orgStudyIdInfo': {'id': 'UPCC 19121'}, 'secondaryIdInfos': [{'id': '850338', 'type': 'OTHER', 'domain': 'University of Pennsylvania'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.', 'type': 'OTHER', 'description': 'Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Abramson Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Julia T. Lewandowski', 'role': 'CONTACT', 'email': 'Julia.Lewandowski@Pennmedicine.upenn.edu', 'phone': '215-662-2861'}, {'name': 'Jennifer Zhang, MD', 'role': 'CONTACT', 'email': 'Jennifer.Zhang@Pennmedicine.upenn.edu', 'phone': '215-615-6810'}], 'overallOfficials': [{'name': 'Jennifer Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Jennifer Zhang', 'investigatorAffiliation': 'Abramson Cancer Center at Penn Medicine'}}}}