Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
Study NCT ID:
NCT02950259
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2016-10-28
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'C067316', 'term': 'Geritol'}, {'id': 'D014815', 'term': 'Vitamins'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000078622', 'term': 'Nutrients'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.page2@providence.org', 'phone': '503-215-6588', 'title': 'Dr. David B. Page', 'organization': 'Earle A. Chiles Research Institute, Providence Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year, 3 months', 'description': 'Adverse event monitoring/recording happened at set time intervals as per study protocol', 'eventGroups': [{'id': 'EG000', 'title': 'IRX-2 Regimen -Early Stage Breast Cancer', 'description': 'Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IRX-2 Regimen -Triple Negative Breast Cancer', 'description': 'Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising/Bruising at Injection Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu-like Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Axillary Lymph Node Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Breast Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Pain with Injections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain with Injections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IRX-2 Regimen -Early Stage Breast Cancer', 'description': 'Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}, {'id': 'OG001', 'title': 'IRX-2 Regimen -Triple Negative Breast Cancer', 'description': 'Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 26', 'description': 'The safety of IRX-2 will be determined by any surgical delays associated with administration of the study regimen.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients were enrolled into Arm B due to poor accrual and opted against Arm B in favor of the NeoIRX trial.'}, {'type': 'SECONDARY', 'title': 'Tumor Infiltrating Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IRX-2 Regimen -Early Stage Breast Cancer', 'description': 'Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}, {'id': 'OG001', 'title': 'IRX-2 Regimen -Triple Negative Breast Cancer', 'description': 'Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '12.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At time of pre-surgical biopsy and time of tumor specimen resection at day 26', 'description': 'Change in tumor infiltrating lymphocyte (TIL) score as measured by hematoxylin and eosin tumor infiltrating lymphocytes (H\\&E TIL) count according to Salgado criteria from pre-surgical biopsy to resected tumor specimen', 'unitOfMeasure': 'percentage of stromal area', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Characterization of Peripheral Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IRX-2 Regimen -Early Stage Breast Cancer', 'description': 'Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}, {'id': 'OG001', 'title': 'IRX-2 Regimen -Triple Negative Breast Cancer', 'description': 'Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}], 'classes': [{'title': 'Stroma, Any PD-L1: T-Cell (any type)', 'categories': [{'measurements': [{'value': '2.01', 'groupId': 'OG000', 'lowerLimit': '1.32', 'upperLimit': '3.08'}]}]}, {'title': 'Stroma, Any PD-L1: Helper T-Cell', 'categories': [{'measurements': [{'value': '2.05', 'groupId': 'OG000', 'lowerLimit': '1.14', 'upperLimit': '3.70'}]}]}, {'title': 'Stroma, Any PD-L1: Cytotoxic T-Cell', 'categories': [{'measurements': [{'value': '2.55', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '3.61'}]}]}, {'title': 'Stroma, Any PD-L1: Regulatory T-Cell', 'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.60', 'upperLimit': '1.39'}]}]}, {'title': 'Stroma, Any PD-L1: Macrophage', 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '1.38'}]}]}, {'title': 'Stroma, PD-L1-positive: T-Cell (any type)', 'categories': [{'measurements': [{'value': '3.54', 'groupId': 'OG000', 'lowerLimit': '1.86', 'upperLimit': '6.76'}]}]}, {'title': 'Stroma, PD-L1-positive: Helper T-Cell', 'categories': [{'measurements': [{'value': '3.58', 'groupId': 'OG000', 'lowerLimit': '1.76', 'upperLimit': '7.29'}]}]}, {'title': 'Stroma, PD-L1-positive: Cytotoxic T-Cell', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000', 'lowerLimit': '1.74', 'upperLimit': '5.08'}]}]}, {'title': 'Stroma, PD-L1-positive: Regulatory T-cell', 'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '2.46'}]}]}, {'title': 'Stroma, PD-L1-positive: Macrophage', 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '3.13'}]}]}, {'title': 'Tumor, Any PD-L1: T-Cell (any type)', 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '1.77'}]}]}, {'title': 'Tumor, Any PD-L1: Helper T-Cell', 'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '1.22'}]}]}, {'title': 'Tumor, Any PD-L1: Cytotoxic T-Cell', 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '2.05'}]}]}, {'title': 'Tumor, Any PD-L1: Regulatory T-Cell', 'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '1.29'}]}]}, {'title': 'Tumor, Any PD-L1: Macrophage', 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '1.09'}]}]}, {'title': 'Tumor, PD-L1-positive: T-Cell (any type)', 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '2.63'}]}]}, {'title': 'Tumor, PD-L1-positive: Helper T-cell', 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '2.04'}]}]}, {'title': 'Tumor, PD-L1-positive: Cytotoxic T-Cell', 'categories': [{'measurements': [{'value': '1.68', 'groupId': 'OG000', 'lowerLimit': '1.06', 'upperLimit': '2.64'}]}]}, {'title': 'Tumor, PD-L1-positive: Regulatory T-Cell', 'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000', 'lowerLimit': '0.32', 'upperLimit': '1.29'}]}]}, {'title': 'Tumor, PD-L1-positive: Macrophage', 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '1.49'}]}]}, {'title': 'Stoma and tumor, PD-L1-positive: PD-L1+ IC^3', 'categories': [{'measurements': [{'value': '3.14', 'groupId': 'OG000', 'lowerLimit': '1.68', 'upperLimit': '5.87'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 26', 'description': 'Fold change of peripheral lymphocytes including activated T-cells, T-regulatory cells, natural killer (NK) cells, and myeloid cells', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to poor accrual we opted against enrolling in Cohort B in favor of the neoIRX trial.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'TIL Phenotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IRX-2 Regimen -Early Stage Breast Cancer', 'description': 'Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}, {'id': 'OG001', 'title': 'IRX-2 Regimen -Triple Negative Breast Cancer', 'description': 'Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}], 'classes': [{'title': 'Any PD-L1: T-cell (any type)', 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'Any PD-L1: Helper T-cell', 'categories': [{'measurements': [{'value': '0.79', 'spread': '.59', 'groupId': 'OG000'}]}]}, {'title': 'Any PD-L1: Cytotoxic T-cell', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.30', 'groupId': 'OG000'}]}]}, {'title': 'Any PD-L1: Regulatory T-cell', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Any PD-L1: Macrophage', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'PD-L1-positive: T-cell (any type)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.59', 'groupId': 'OG000'}]}]}, {'title': 'PD-L1-positive: Helper T-Cell', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.46', 'groupId': 'OG000'}]}]}, {'title': 'PD-L1-positive: Cytotoxic T-Cell', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'PD-L1-positive: Regulatory T-Cell', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': 'PD-L1-positive: Macrophage', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to 26', 'description': 'Post-IRX mean density of T-regulatory cells, activated T-cells, myeloid lineages and dendritic cells post-IRX within stromal tissue compartments.', 'unitOfMeasure': 'count/pixel', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intratumoral T-cell Clonality Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IRX-2 Regimen -Early Stage Breast Cancer', 'description': 'Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}, {'id': 'OG001', 'title': 'IRX-2 Regimen -Triple Negative Breast Cancer', 'description': 'Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}], 'classes': [{'title': 'Patient 1', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Patient 2', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000'}]}]}, {'title': 'Patient 3', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000'}]}]}, {'title': 'Patient 4', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Patient 5', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Patient 6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Patient 7', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Patient 8', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Patient 9', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000'}]}]}, {'title': 'Patient 10', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Patient 11', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Patient 12', 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000'}]}]}, {'title': 'Patient 13', 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000'}]}]}, {'title': 'Patient 14', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Patient did not have available paired lymph node specimen available for analyzation.', 'groupId': 'OG000'}]}]}, {'title': 'Patient 15', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000'}]}]}, {'title': 'Patient 16', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1-26', 'description': 'Change in T-cell clonal responses by T-cell receptor DNA deep sequencing', 'unitOfMeasure': 'fold change', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intratumoral Immune Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IRX-2 Regimen -Early Stage Breast Cancer', 'description': 'Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}, {'id': 'OG001', 'title': 'IRX-2 Regimen -Triple Negative Breast Cancer', 'description': 'Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}], 'classes': [{'title': 'Patient 1', 'categories': [{'measurements': [{'value': '.9', 'groupId': 'OG000'}]}]}, {'title': 'Patient 2', 'categories': [{'measurements': [{'value': '.6', 'groupId': 'OG000'}]}]}, {'title': 'Patient 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Patient 4', 'categories': [{'measurements': [{'value': '.7', 'groupId': 'OG000'}]}]}, {'title': 'Patient 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Patient 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Patient 7', 'categories': [{'measurements': [{'value': '.5', 'groupId': 'OG000'}]}]}, {'title': 'Patient 8', 'categories': [{'measurements': [{'value': '-.5', 'groupId': 'OG000'}]}]}, {'title': 'Patient 9', 'categories': [{'measurements': [{'value': '.5', 'groupId': 'OG000'}]}]}, {'title': 'Patient 10', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Patient 11', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Patient 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Patient 13', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Patient 14', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Patient 15', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Patient 16', 'categories': [{'measurements': [{'value': '.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1-26', 'description': 'The Nanostring PanCancer Immune panel was used to estimate increase in PD-L1 mRNA expression among tumor-bearing FFPE specimens.', 'unitOfMeasure': 'fold change', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IRX-2 Regimen -Early Stage Breast Cancer', 'description': 'Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}, {'id': 'FG001', 'title': 'IRX-2 Regimen -Triple Negative Breast Cancer', 'description': 'Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IRX-2 Regimen -Early Stage Breast Cancer', 'description': 'Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}, {'id': 'BG001', 'title': 'IRX-2 Regimen -Triple Negative Breast Cancer', 'description': 'Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.\n\nCyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion\n\nIndomethacin: Indomethacin 25 mg three times a day for 21 days\n\nOmeprazole: One tablet of omeprazole daily for 21 days\n\nMultivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Menstrual Status', 'classes': [{'categories': [{'title': 'Premenopausal', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Post-menopausal', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Family History of Breast/Ovarian Cancer', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown/Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Known BRCA 1/2 Mutation', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Due to poor accrual, site opted against enrolling patients into cohort B in favor of a different trial which is ongoing.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-19', 'size': 320114, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-27T10:57', 'hasProtocol': True}, {'date': '2018-01-24', 'size': 224176, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-04-27T10:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2016-10-28', 'resultsFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2016-10-28', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-01-25', 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Characterization of Peripheral Lymphocytes', 'timeFrame': 'Day 1 to Day 26', 'description': 'Fold change of peripheral lymphocytes including activated T-cells, T-regulatory cells, natural killer (NK) cells, and myeloid cells'}, {'measure': 'TIL Phenotype', 'timeFrame': 'Day 1 to 26', 'description': 'Post-IRX mean density of T-regulatory cells, activated T-cells, myeloid lineages and dendritic cells post-IRX within stromal tissue compartments.'}, {'measure': 'Intratumoral T-cell Clonality Response', 'timeFrame': 'Day 1-26', 'description': 'Change in T-cell clonal responses by T-cell receptor DNA deep sequencing'}, {'measure': 'Intratumoral Immune Response', 'timeFrame': 'Day 1-26', 'description': 'The Nanostring PanCancer Immune panel was used to estimate increase in PD-L1 mRNA expression among tumor-bearing FFPE specimens.'}], 'primaryOutcomes': [{'measure': 'Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients', 'timeFrame': 'Day 1 to Day 26', 'description': 'The safety of IRX-2 will be determined by any surgical delays associated with administration of the study regimen.'}], 'secondaryOutcomes': [{'measure': 'Tumor Infiltrating Lymphocytes', 'timeFrame': 'At time of pre-surgical biopsy and time of tumor specimen resection at day 26', 'description': 'Change in tumor infiltrating lymphocyte (TIL) score as measured by hematoxylin and eosin tumor infiltrating lymphocytes (H\\&E TIL) count according to Salgado criteria from pre-surgical biopsy to resected tumor specimen'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Early Stage Breast Cancer', 'Male breast cancer', 'IRX-2', 'Immunotherapy', 'Triple Negative Breast Cancer'], 'conditions': ['Breast Neoplasm', 'Breast Neoplasm, Male', 'Triple Negative Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '33413574', 'type': 'DERIVED', 'citation': 'Sanchez K, Kim I, Chun B, Pucilowska J, Redmond WL, Urba WJ, Martel M, Wu Y, Campbell M, Sun Z, Grunkemeier G, Chang SC, Bernard B, Page DB. Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer. Breast Cancer Res. 2021 Jan 7;23(1):2. doi: 10.1186/s13058-020-01378-4.'}], 'seeAlsoLinks': [{'url': 'https://oregon.providence.org/our-services/p/providence-cancer-center/', 'label': 'Providence Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients with early stage breast cancer (ESBC) and to estimate the pathologic complete response rate to neoadjuvant anthracycline-based and non-platinum containing chemotherapy in patients with triple-negative breast cancer who have received the IRX-2 Regimen before chemotherapy.', 'detailedDescription': 'This will be a Phase Ib study conducted to determine the safety and tolerability of an IRX-2 regimen in ESBC, to be administered pre-operatively before standard-of-care surgical resection and following standard-of-care diagnostic biopsy. This study will also include triple-negative breast cancer patients who will receive the IRX-2 regimen prior to chemotherapy.\n\nEligible subjects will have early stage breast cancer of any receptor sub-type, for which standard-of-care surgical resection is planned. To be eligible, a minimum of 1 core of tumor-bearing biopsy material must be available for research analysis.\n\nCohort B will enroll subjects triple negative breast cancer (defined by ER\\<10%, PR\\<10%, and HER2-negative by NCCN guidelines), T1c+ tumors for which neoadjuvant anthracycline-based and non-platinum containing chemotherapy is planned. The IRX-2 regimen will be administered and completed preceding chemotherapy. Cohort B subjects must undergo post-IRX-2 Regimen biopsy (2-3 cores), followed by commencement of chemotherapy preferably within one week after biopsy.\n\nThe IRX-2 regimen will be administered in all enrolled subjects. IRX 2 will be administered by subcutaneous injection into the periareolar skin of the affected breast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Invasive breast cancer of any receptor subtype diagnosed by core-needle biopsy\n* To undergo surgical resection with curative intent by partial mastectomy (lumpectomy) or mastectomy or\n* Triple negative breast cancer (defined by ER\\<10%, PR\\<10%, and HER2-negative by NCCN guidelines), T1c+ tumors for which neoadjuvant anthracycline-based and non-platinum containing chemotherapy is planned\n* Tumor \\>5 mm in maximum diameter by ultrasound or mammography. (Subjects with smaller tumors may be included at the discretion of the Principal Investigator.)\n* Willing and able to provide written informed consent, including consent for use of available tissue and required blood draws for research purposes\n* Availability of at least one tumor-bearing core specimen from the breast cancer diagnostic biopsy\n* Karnofsky Performance status (KPS) 70% or greater.\n* Female or male ≥18 years of age on day of signing informed consent.\n* Adequate organ function as defined by protocol specified lab results\n\nExclusion Criteria:\n\n* Prior neoadjuvant systemic therapy is planned\n* Prior surgery, radiotherapy or chemotherapy for this cancer (other than core-needle biopsy)\n* Received an investigational agent within 4 weeks of the first dose of treatment.\n* Diagnosis of immunodeficiency or has received more than replacement doses of corticosteroids any other immunosuppressive therapy within 4 weeks of the first dose of treatment\n* Hypersensitivity to IRX 2, cyclophosphamide, indomethacin, aspirin or ciprofloxacin.\n* Chronic anticoagulation, not including aspirin, but including heparins, warfarin, oral anticoagulants or other platelet function inhibitors, that cannot, in the documented opinion of the investigator, safely be interrupted from at least 2 days prior to the initiation of the study regimen until after surgical resection of the tumor.\n* Another malignancy that required active treatment within 6 months of the first dose of treatment\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, such that trial participation is not in the best interest of the subject, including but not limited to uncontrolled hypertension or clinically significant cardiovascular disease, myocardial infarction within the previous 3 months, active infection or pneumonitis or other pulmonary disease requiring systemic therapy, clinically significant gastritis or peptic ulcer disease (that would preclude the use of indomethacin), stroke of other symptoms of cerebral vascular insufficient within the last 3 months, autoimmune disease that has required systemic treatment within the past 2 years (other than hormone replacement doses), or uncontrolled psychiatric or substance abuse disorders.\n* Pregnancy or lactation.\n* Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected)."}, 'identificationModule': {'nctId': 'NCT02950259', 'briefTitle': 'Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)', 'organization': {'class': 'OTHER', 'fullName': 'Providence Health & Services'}, 'officialTitle': 'A Phase Ib Study to Assess the Safety, Tolerability and Immunologic Activity of Preoperative IRX 2 In Early Stage Breast Cancer', 'orgStudyIdInfo': {'id': '16-126B'}, 'secondaryIdInfos': [{'id': 'IRX-2 2016-B', 'type': 'OTHER', 'domain': 'IRX Therapeutics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IRX-2 Regimen -Early Stage Breast Cancer', 'description': 'Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Indomethacin', 'Drug: Omeprazole', 'Dietary Supplement: Multivitamin']}, {'type': 'EXPERIMENTAL', 'label': 'IRX-2 Regimen -Triple Negative Breast Cancer', 'description': 'Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Indomethacin', 'Drug: Omeprazole', 'Dietary Supplement: Multivitamin']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': 'One dose of cyclophosphamide 300 mg/m2 IV infusion', 'armGroupLabels': ['IRX-2 Regimen -Early Stage Breast Cancer', 'IRX-2 Regimen -Triple Negative Breast Cancer']}, {'name': 'Indomethacin', 'type': 'DRUG', 'otherNames': ['Indocin'], 'description': 'Indomethacin 25 mg three times a day for 21 days', 'armGroupLabels': ['IRX-2 Regimen -Early Stage Breast Cancer', 'IRX-2 Regimen -Triple Negative Breast Cancer']}, {'name': 'Omeprazole', 'type': 'DRUG', 'otherNames': ['Prilosec'], 'description': 'One tablet of omeprazole daily for 21 days', 'armGroupLabels': ['IRX-2 Regimen -Early Stage Breast Cancer', 'IRX-2 Regimen -Triple Negative Breast Cancer']}, {'name': 'Multivitamin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Vitamin'], 'description': 'Daily multivitamin containing 15-30 mg of zinc for 21 days.', 'armGroupLabels': ['IRX-2 Regimen -Early Stage Breast Cancer', 'IRX-2 Regimen -Triple Negative Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Portland Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'David Page, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence Health & Services'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '5 years', 'ipdSharing': 'YES', 'description': 'Providence Health \\& Services has agreed to allow IRX Therapeutics to have access PHI for auditing purposes. Any non-Providence Health \\& Services employee who will access PHI will be required to sign a confidentiality agreement and will not be permitted to remove PHI from Providence Health \\& Services.', 'accessCriteria': 'IPD will be accessed for data verification purposes only.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Providence Health & Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brooklyn ImmunoTherapeutics, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}