Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-29 @ 10:13 AM
Study NCT ID:
NCT03887702
Status:
TERMINATED
Last Update Posted:
2024-05-20
First Post:
2019-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'C413685', 'term': 'entecavir'}, {'id': 'C442442', 'term': 'tenofovir alafenamide'}, {'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adarke@fredhutch.org', 'phone': '2066674623', 'title': 'SWOG Statistician', 'organization': 'SWOG Statistics and Data Management Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'On November 15, 2022, the study was discontinued with no further follow-up required after it was determined that the accrual goal could not be met. Four participants had been accrued to Cohort 2 and no participants to Cohort 1. No adverse liver events, hepatitis B flares, or hepatitis B reactivations had occurred at the time the study was discontinued. As a result, planned time-to-event analyses for these outcomes could not be completed.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected over 2 years, but, with the exception of study endpoints, adverse events were only collected after participants began treatment with anti-HBV therapy.', 'description': 'No participants received experimental treatment on this study. No participants were registered in the Chronic HBV cohort \\[Cohort 1\\]. In the Past HBV cohort \\[Cohort 2\\]:\n\n* no participants assigned to Arm 3 experienced HBV reactivation, which would have prompted treatment with the study-assigned anti-HBV therapy according to protocol\n* one participant in Arm 4 (standard of care) began anti-HBV therapy at physician discretion.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1 (TAF, TDF, Entecavir: Prophylactic)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm 3 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 2\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Arm 4 (Anti-Viral Therapy: Usual Care)', 'description': '\\[Cohort 2\\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for HBV may be used.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Liver Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 (TAF, TDF, Entecavir: Prophylactic)', 'description': '\\[Cohort 1\\] Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (TDF) PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm 2 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm 3 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 2\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Arm 4 (Anti-Viral Therapy: Usual Care)', 'description': '\\[Cohort 2\\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to 24 months', 'description': 'Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no participants registered to the Chronic HBV infection cohort \\[Cohort 1, Arms 1 and 2\\]'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hepatitis B Virus (HBV) Reactivation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 (TAF, TDF, Entecavir: Prophylactic)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO'}, {'id': 'OG001', 'title': 'Arm 2 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO'}, {'id': 'OG002', 'title': 'Arm 3 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 2\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO'}, {'id': 'OG003', 'title': 'Arm 4 (Anti-Viral Therapy: Usual Care)', 'description': '\\[Cohort 2\\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.\n\nBest Practice: Receive best practice\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization up to 24 months', 'description': 'HBV reactivation is is defined as one of the following:\n\n* ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or\n* HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or\n* HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or\n* HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no participants registered to the Chronic HBV infection cohort \\[Cohort 1, Arms 1 and 2\\]'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hepatitis B Virus (HBV) Flare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 (TAF, TDF, Entecavir: Prophylactic)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO'}, {'id': 'OG001', 'title': 'Arm 2 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO'}, {'id': 'OG002', 'title': 'Arm 3 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 2\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO'}, {'id': 'OG003', 'title': 'Arm 4 (Anti-Viral Therapy: Usual Care)', 'description': '\\[Cohort 2\\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.\n\nBest Practice: Receive best practice\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to 24 months', 'description': 'Hepatitis flare is defined as ALT \\> 3 x baseline and \\>100 U/L.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no participants registered to the Chronic HBV infection cohort \\[Cohort 1, Arms 1 and 2\\]'}, {'type': 'SECONDARY', 'title': 'Combined Endpoint of Adverse Liver Outcomes and HBV Reactivation, Number of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 (TAF, TDF, Entecavir: Prophylactic)', 'description': '\\[Cohort 1\\] Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (TDF) PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm 2 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm 3 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 2\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Arm 4 (Anti-Viral Therapy: Usual Care)', 'description': '\\[Cohort 2\\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to 24 months', 'description': 'Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review.\n\nHBV reactivation is defined as one of the following:\n\n* ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or\n* HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or\n* HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or\n* HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-.\n\nThe combined endpoint of adverse liver outcomes and HBV reactivation is the occurrence of either adverse liver outcome or HBV reactivation as defined above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no participants registered to the Chronic HBV infection cohort \\[Cohort 1, Arms 1 and 2\\]'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1 (TAF, TDF, Entecavir: Prophylactic)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO'}, {'id': 'FG001', 'title': 'Arm 2 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO'}, {'id': 'FG002', 'title': 'Arm 3 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 2\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nEntecavir: Given PO\n\nTenofovir Alafenamide: Given PO\n\nTenofovir Disoproxil Fumarate: Given PO'}, {'id': 'FG003', 'title': 'Arm 4 (Anti-Viral Therapy: Usual Care)', 'description': '\\[Cohort 2\\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for HBV may be used.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'This represents the number of participants registered to the arms.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Received Anti-HBV Treatment Per Assignment', 'comment': 'This represents the number of participants who actually received any anti-viral HBV therapy on their assigned study arm (Arms 2 and 3 are upon indication; Arm 4 is physician discretion with any anti-HBV therapy allowed)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1 (TAF, TDF, Entecavir: Prophylactic)', 'description': '\\[Cohort 1\\] Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (TDF) PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG001', 'title': 'Arm 2 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Arm 3 (TAF, TDF, Entecavir: Upon Indication)', 'description': '\\[Cohort 2\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG003', 'title': 'Arm 4 (Anti-Viral Therapy: Usual Care)', 'description': '\\[Cohort 2\\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'groupId': 'BG002', 'lowerLimit': '45.5', 'upperLimit': '49.5'}, {'value': '75.4', 'groupId': 'BG003', 'lowerLimit': '64.4', 'upperLimit': '86.3'}, {'value': '62.45', 'groupId': 'BG004', 'lowerLimit': '45.5', 'upperLimit': '86.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'There were no participants registered to the Chronic HBV infection cohort \\[Cohort 1, Arms 1 and 2\\]'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-02', 'size': 981179, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-02T13:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'inability to accrue', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2019-03-21', 'resultsFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-17', 'studyFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Liver Outcome', 'timeFrame': 'From randomization to 24 months', 'description': 'Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Hepatitis B Virus (HBV) Reactivation', 'timeFrame': 'From randomization up to 24 months', 'description': 'HBV reactivation is is defined as one of the following:\n\n* ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or\n* HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or\n* HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or\n* HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-.'}, {'measure': 'Number of Participants With Hepatitis B Virus (HBV) Flare', 'timeFrame': 'From randomization to 24 months', 'description': 'Hepatitis flare is defined as ALT \\> 3 x baseline and \\>100 U/L.'}, {'measure': 'Combined Endpoint of Adverse Liver Outcomes and HBV Reactivation, Number of Participants', 'timeFrame': 'From randomization to 24 months', 'description': 'Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review.\n\nHBV reactivation is defined as one of the following:\n\n* ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or\n* HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or\n* HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or\n* HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-.\n\nThe combined endpoint of adverse liver outcomes and HBV reactivation is the occurrence of either adverse liver outcome or HBV reactivation as defined above.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B Infection', 'Malignant Solid Neoplasm']}, 'descriptionModule': {'briefSummary': 'This phase III trial studies the effect of hepatitis B antiviral (anti-HBV) therapy in preventing liver complications in patients with chronic or past hepatitis B virus (HBV) who are receiving anti-cancer therapy for solid tumors. People with chronic or past HBV who are undergoing therapy for cancer are at an increased risk for changes in the liver which could be minor or severe. Anti-HBV therapy acts against infections caused by HBV and may help reduce the chance that HBV gets worse or comes back in patients receiving anti-cancer therapy for solid tumors.', 'detailedDescription': 'Co-Primary Objectives\n\n1. To compare the effect of prophylactic anti-HBV therapy versus upon indication anti-HBV therapy on time-to-adverse liver outcomes of liver failure or liver-related death in patients with chronic HBV infection (HBsAg+ and anti-HBc+) receiving anti-cancer therapy for solid tumors.\n2. To compare the effect of upon indication anti-HBV therapy versus usual care on time-to-adverse liver outcomes of liver failure or liver-related death in patients with past HBV infection (HBsAg- and anti-HBc+) receiving anti-cancer therapy for solid tumors.\n\nSecondary Objectives\n\n1. Using time-to-event analysis, to compare the effect of anti-HBV therapy versus upon indication anti-HBV therapy on HBV reactivation, on the combined endpoint of adverse liver outcomes (liver failure or liver-related death) and HBV reactivation, and on HBV flare by arm in patients with chronic HBV infection receiving anticancer therapy for solid tumors.\n2. Using time-to-event analysis, to compare the effect of upon indication anti-HBV therapy versus usual care on HBV reactivation, on the combined endpoint of adverse liver outcomes (liver failure or liver-related death) and HBV reactivation, and on HBV flare by arm in patients with past HBV infection receiving anti-cancer therapy for solid tumors.\n\nTranslational Objectives\n\n1. To compare baseline and changes in overall immune status and HBV-specific immune response in patients with solid tumors and chronic or past HBV infection receiving anti-cancer therapy, and to compare the differences in these immune responses by HBV reactivation status.\n2. To identify demographic and clinical predictors and correlative immunologic biomarkers of HBV reactivation after receipt of anti-cancer therapy in patients with solid tumors and chronic or past HBV infection.\n\nOUTLINE: Patients are recruited in two cohorts (Cohort 1: chronic HBV infection, Cohort 2: past HBV infection), with each cohort randomized equally to one of two potential treatment arms.\n\nChronic HBV Infection (Cohort 1) Arms:\n\nArm 1: Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (TDF) PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nArm 2: Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nPast HBV infection (Cohort 2) Arms:\n\nArm 3: Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.\n\nArm 4: Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for HBV may be used.\n\n(Cohort 1: Arm 2 and Cohort 2: Arm 3 follow the same treatment plan, but are considered part of separate parallel studies and are therefore identified as separate arms.)\n\nPatients are followed for 24 months: every 4 weeks from randomization to week 24, then every 8 weeks thereafter up to week 104.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be diagnosed with stage I-III solid tumor malignancy; patients with only carcinoma in situ or with stage IV disease are excluded\n* Patients must not have lymphoma, leukemia, or myeloma\n* Patients must not have primary liver cancer, known cirrhosis, or evidence of any malignancy that involves the liver\n* Patients must be planning to receive systemic anti-cancer therapy (either single agent or some combination of systemic cytotoxic therapy, systemic immunotherapy or systemic targeted therapy) for this solid tumor\n* Patients must not have been previously treated with the same anti-cancer therapy regimen that is now anticipated; the anti-cancer therapy does not have to be first-line therapy; prior and/or concurrent radiotherapy is allowed\n* Patients must be registered \\<= 28 days prior to the planned start date of anti-cancer therapy; if the patient has started systemic anti-cancer therapy, patient must be registered \\<= 42 days after the initiation of first cycle of anti-cancer therapy\n* Patients who have received prior anti-cancer therapy must have discontinued all previous therapies (excluding planned anti-cancer therapy to occur in conjunction with this study) \\>= 1 day prior to registration to this study\n* Patients must not have had any cancer therapy regimen that includes anti-CD20\n* Patients must not be receiving antiviral medications active against HBV, including: adefovir, entecavir, lamivudine, telbivudine, tenofovir disoproxil fumarate, tenofovir alafenamide (TAF), or any other Food and Drug Administration (FDA) approved agents for the treatment of hepatitis B; patients who have previously received antiviral medication must not have required any antiviral medication active against HBV \\>= 90 days prior to registration to this study\n* Patients must not have had hematopoietic stem cell transplantation therapy\n* Patients must not be taking or planning to take warfarin\n* Patients who will be treated with TAF must not be taking or planning to take oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John\'s Wort\n* Patients who will be treated with TAF and are concomitantly taking or plan to take carbamazepine must be given an increased dose of TAF or alternatively be given ETV or TDF\n* Patients must have results for the following HBV tests done within 28 days prior to registration: HBsAg AND anti-HBc (total immunoglobulin \\[Ig\\] or IgG, but not IgM only) AND hepatitis B surface antibody (anti-HBs); for the anti-HBs test, quantitative or qualitative (including "indeterminate") results are allowable\n* Patients must have tested positive for HBsAg or anti-HBc (total Ig, IgG, but not IgM) and must have baseline HBV deoxyribonucleic acid (DNA) completed \\<= 42 days prior to registration\n* Complete blood count (CBC) must be completed \\<= 28 days prior to registration; results do not need to be in the institutional limits of normal\n* International normalized ratio (INR) must be completed \\<= 28 days prior to registration; results must \\<= 1.2 x institutional limits of normal\n* Alanine aminotransferase (ALT) must be obtained \\<= 28 days prior to registration; ALT must be \\< 1.5 x institutional ULN\n* Total bilirubin must be obtained \\<= 28 days prior to registration; total bilirubin must be \\< 1.5 x institutional ULN\n* Creatinine results must be obtained \\<= 28 days prior to registration\n* Patients must not have known current active hepatitis C infection (HCV); active HCV is defined by a detectable HCV ribonucleic acid (RNA) level; Note: HCV testing is not required for eligibility\n* Patients must not have a history of human immunodeficiency (HIV) infection; patients with unknown HIV status must have HIV testing completed \\<= 365 days prior to registration\n* Patients must have Zubrod performance status of 0-2\n* Patients must not be pregnant or nursing, as the safety of the study drug in pregnant and nursing women has not been established; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures\n* Patients must have specimens collected for submission as outlined\n* Patients must be offered the opportunity to participate in optional translational medicine studies as outlined\n* Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\n* Patients may have concurrent participation in other clinical trials that entail cytotoxic, immunotherapy, targeted therapy; surgical treatment; radiotherapy treatment; or any combination thereof\n* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\n* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'}, 'identificationModule': {'nctId': 'NCT03887702', 'briefTitle': 'Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors', 'orgStudyIdInfo': {'id': 'S1614'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00592', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'S1614', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'SWOG-S1614', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'S1614', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'UG1CA189974', 'link': 'https://reporter.nih.gov/quickSearch/UG1CA189974', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 (TAF, TDF, entecavir: prophylactic)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Entecavir', 'Drug: Tenofovir Alafenamide', 'Drug: Tenofovir Disoproxil Fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 (TAF, TDF, entecavir: upon indication)', 'description': '\\[Cohort 1\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Entecavir', 'Drug: Tenofovir Alafenamide', 'Drug: Tenofovir Disoproxil Fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 (TAF, TDF, entecavir: upon indication)', 'description': '\\[Cohort 2\\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Entecavir', 'Drug: Tenofovir Alafenamide', 'Drug: Tenofovir Disoproxil Fumarate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4 (Anti-Viral therapy: usual care)', 'description': '\\[Cohort 2\\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.', 'interventionNames': ['Other: Best Practice', 'Drug: Entecavir', 'Drug: Tenofovir Alafenamide', 'Drug: Tenofovir Disoproxil Fumarate']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive best practice', 'armGroupLabels': ['Arm 4 (Anti-Viral therapy: usual care)']}, {'name': 'Entecavir', 'type': 'DRUG', 'otherNames': ['Baraclude', 'BMS-200475-01', 'ETV', 'SQ-34676', 'SQ34676'], 'description': 'Given PO', 'armGroupLabels': ['Arm 1 (TAF, TDF, entecavir: prophylactic)', 'Arm 2 (TAF, TDF, entecavir: upon indication)', 'Arm 3 (TAF, TDF, entecavir: upon indication)', 'Arm 4 (Anti-Viral therapy: usual care)']}, {'name': 'Tenofovir Alafenamide', 'type': 'DRUG', 'otherNames': ['GS 7340', 'GS-7340', 'TFV Alafenamide'], 'description': 'Given PO', 'armGroupLabels': ['Arm 1 (TAF, TDF, entecavir: prophylactic)', 'Arm 2 (TAF, TDF, entecavir: upon indication)', 'Arm 3 (TAF, TDF, entecavir: upon indication)', 'Arm 4 (Anti-Viral therapy: usual care)']}, {'name': 'Tenofovir Disoproxil Fumarate', 'type': 'DRUG', 'otherNames': ['PMPA Prodrug', 'TDF', 'Tenofovir DF', 'Viread'], 'description': 'Given PO', 'armGroupLabels': ['Arm 1 (TAF, TDF, entecavir: prophylactic)', 'Arm 2 (TAF, TDF, entecavir: upon indication)', 'Arm 3 (TAF, TDF, entecavir: upon indication)', 'Arm 4 (Anti-Viral therapy: usual care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72903', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Mercy Hospital Fort Smith', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '92806', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Anaheim', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '94531', 'city': 'Antioch', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Deer Valley Medical Center', 'geoPoint': {'lat': 38.00492, 'lon': -121.80579}}, {'zip': '91706', 'city': 'Baldwin Park', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Baldwin Park', 'geoPoint': {'lat': 34.08529, 'lon': -117.9609}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Bellflower', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '94568', 'city': 'Dublin', 'state': 'California', 'country': 'United States', 'facility': 'Epic Care-Dublin', 'geoPoint': {'lat': 37.70215, 'lon': -121.93579}}, {'zip': '94568', 'city': 'Dublin', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Dublin', 'geoPoint': {'lat': 37.70215, 'lon': -121.93579}}, {'zip': '94608', 'city': 'Emeryville', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Breast Surgeons Inc', 'geoPoint': {'lat': 37.83132, 'lon': -122.28525}}, {'zip': '94608', 'city': 'Emeryville', 'state': 'California', 'country': 'United States', 'facility': 'Epic Care Partners in Cancer Care', 'geoPoint': {'lat': 37.83132, 'lon': -122.28525}}, {'zip': '92335', 'city': 'Fontana', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Fontana', 'geoPoint': {'lat': 34.09223, 'lon': -117.43505}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Fremont', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Fresno Cancer Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90710', 'city': 'Harbor City', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente - Harbor City', 'geoPoint': {'lat': 33.79002, 'lon': -118.29785}}, {'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Tibor Rubin VA Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles County-USC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC / Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90034', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente West Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94553-3156', 'city': 'Martinez', 'state': 'California', 'country': 'United States', 'facility': 'Contra Costa Regional Medical Center', 'geoPoint': {'lat': 38.01937, 'lon': -122.13413}}, {'zip': '95356', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Modesto', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'USC Norris Oncology/Hematology-Newport Beach', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center - Summit Campus', 'geoPoint': 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