Breast Cancer Clinical Trial
Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors
Summary
This phase III trial studies the effect of tenofovir alafenamide in preventing liver complications in patients with current 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. Tenofovir alafenamide is a drug that 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.
Full Description
PRIMARY OBJECTIVES:
I. 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 (hepatitis B surface antigen positive [HBsAg+] and antibody to hepatitis B core antigen positive [anti-HBc+]) receiving anti-cancer therapy for solid tumors.
II. 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 (hepatitis B surface antigen negative [HBsAg-] and anti-HBc+) receiving anti-cancer therapy for solid tumors.
SECONDARY OBJECTIVES:
I. 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 anti-cancer therapy for solid tumors.
II. 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.
TRANSLATIONAL OBJECTIVES:
I. 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.
II. 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.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP A (Cohorts 1a & 2a): 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.
GROUP B (Cohorts 1b & 2b): 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.
GROUP C (Cohort 3): Patients receive TAF PO QD or TDF PO QD or entecavir PO QD at the discretion of the physician during usual care. Treatment continues for up to 6 months after discontinuation of usual care or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks for up to 24 months.
Eligibility Criteria
Inclusion Criteria:
Patients must be diagnosed with stage I-III solid tumor malignancy; patients with only carcinoma in situ or with stage IV disease are excluded
Patients must not have been diagnosed with a malignancy other than the current malignancy within the past five years, with the exception of basal cell or squamous cell skin cancer, or non-invasive (in situ) malignancies of the cervix, breast, or skin
Patients must not have lymphoma, leukemia, or myeloma
Patients must not have primary liver cancer, known cirrhosis, or evidence of any malignancy that involves the liver
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
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
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
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
Patients must not have had any cancer therapy regimen that includes anti-CD20
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
Patients must not have had hematopoietic stem cell transplantation therapy
Patients receiving any of the following medications must discontinue them (under the supervision of their treating physician) prior to registration, and must not be planning to take them during protocol therapy: acyclovir, aminoglycosides, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, valacyclovir, high-dose nonsteroidal anti-inflammatory drugs (NSAIDs), ("high-dose" based on package insert), and St. John's wort
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
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
Complete blood count (CBC) must be completed =< 28 days prior to registration; results do not need to be in the institutional limits of normal
International normalized ratio (INR) must be completed =< 28 days prior to registration; results must < 1.2 x institutional limits of normal
Alanine aminotransferase (ALT) must be obtained =< 28 days prior to registration; ALT must be =< 1.5 x institutional ULN
Total bilirubin must be obtained =< 28 days prior to registration; total bilirubin must be =< 1.5 x institutional ULN
Creatinine results must be obtained =< 28 days prior to registration; creatinine must be =< 1.5 x institutional ULN
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
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
Patients must have Zubrod performance status of 0-2
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
Patients must have specimens collected for submission as outlined
Patients must be offered the opportunity to participate in optional translational medicine studies as outlined
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)
Patients may have concurrent participation in other clinical trials that entail cytotoxic, immunotherapy, targeted therapy; surgical treatment; radiotherapy treatment; or any combination thereof
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
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
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There are 162 Locations for this study
Fort Smith Arkansas, 72903, United States More Info
Principal Investigator
Anaheim California, 92806, United States More Info
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Antioch California, 94531, United States More Info
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Baldwin Park California, 91706, United States More Info
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Bellflower California, 90706, United States More Info
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Dublin California, 94568, United States More Info
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Dublin California, 94568, United States More Info
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Emeryville California, 94608, United States More Info
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Emeryville California, 94608, United States More Info
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Fontana California, 92335, United States More Info
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Fremont California, 94538, United States More Info
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Fresno California, 93720, United States More Info
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Fresno California, 93720, United States More Info
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Harbor City California, 90710, United States More Info
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Irvine California, 92618, United States More Info
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Long Beach California, 90822, United States More Info
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Los Angeles California, 90027, United States More Info
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Los Angeles California, 90033, United States More Info
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Los Angeles California, 90033, United States More Info
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Los Angeles California, 90034, United States More Info
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Martinez California, 94553, United States More Info
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Modesto California, 95356, United States More Info
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Newport Beach California, 92663, United States More Info
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Oakland California, 94609, United States More Info
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Oakland California, 94609, United States More Info
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Oakland California, 94611, United States More Info
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Oakland California, 94611, United States More Info
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Ontario California, 91761, United States More Info
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Panorama City California, 91402, United States More Info
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Pasadena California, 91105, United States More Info
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Rancho Cordova California, 95670, United States More Info
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Redwood City California, 94063, United States More Info
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Richmond California, 94801, United States More Info
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Riverside California, 92505, United States More Info
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Rohnert Park California, 94928, United States More Info
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Roseville California, 95661, United States More Info
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Roseville California, 95678, United States More Info
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Sacramento California, 95814, United States More Info
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Sacramento California, 95823, United States More Info
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Sacramento California, 95823, United States More Info
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Sacramento California, 95825, United States More Info
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San Diego California, 92120, United States More Info
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San Francisco California, 94115, United States More Info
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San Jose California, 95119, United States More Info
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San Leandro California, 94577, United States More Info
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San Marcos California, 92078, United States More Info
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San Rafael California, 94903, United States More Info
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San Rafael California, 94903, United States More Info
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Santa Clara California, 95051, United States More Info
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Santa Rosa California, 95403, United States More Info
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South San Francisco California, 94080, United States More Info
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South San Francisco California, 94080, United States More Info
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Stockton California, 95210, United States More Info
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Vacaville California, 95688, United States More Info
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Vallejo California, 94589, United States More Info
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Walnut Creek California, 94596, United States More Info
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Walnut Creek California, 94597, United States More Info
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Woodland Hills California, 91367, United States More Info
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Deerfield Beach Florida, 33064, United States
Fort Lauderdale Florida, 33316, United States
Savannah Georgia, 31405, United States More Info
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'Aiea Hawaii, 96701, United States More Info
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'Aiea Hawaii, 96701, United States More Info
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'Aiea Hawaii, 96701, United States More Info
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'Aiea Hawaii, 96701, United States More Info
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'Ewa Beach Hawaii, 96706, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96817, United States More Info
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Honolulu Hawaii, 96817, United States More Info
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Honolulu Hawaii, 96817, United States More Info
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Honolulu Hawaii, 96817, United States More Info
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Honolulu Hawaii, 96817, United States More Info
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Honolulu Hawaii, 96819, United States More Info
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Honolulu Hawaii, 96826, United States More Info
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Kailua Hawaii, 96734, United States More Info
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Lihue Hawaii, 96766, United States More Info
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Boise Idaho, 83706, United States More Info
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Caldwell Idaho, 83605, United States More Info
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Coeur d'Alene Idaho, 83814, United States More Info
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Emmett Idaho, 83617, United States More Info
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Meridian Idaho, 83642, United States More Info
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Nampa Idaho, 83686, United States More Info
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Post Falls Idaho, 83854, United States More Info
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Sandpoint Idaho, 83864, United States More Info
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Alton Illinois, 62002, United States More Info
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Aurora Illinois, 60504, United States More Info
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Chicago Illinois, 60611, United States More Info
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Danville Illinois, 61832, United States More Info
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Effingham Illinois, 62401, United States More Info
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Mattoon Illinois, 61938, United States More Info
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Mount Vernon Illinois, 62864, United States More Info
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Urbana Illinois, 61801, United States More Info
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Urbana Illinois, 61801, United States More Info
Principal Investigator
Yorkville Illinois, 60560, United States More Info
Principal Investigator
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Garden City Kansas, 67846, United States
Great Bend Kansas, 67530, United States More Info
Principal Investigator
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Lenexa Kansas, 66219, United States
Lenexa Kansas, 66219, United States
Liberal Kansas, 67905, United States
Manhattan Kansas, 66502, United States
McPherson Kansas, 67460, United States
Newton Kansas, 67114, United States
Overland Park Kansas, 66209, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Monroe Louisiana, 71202, United States
Shreveport Louisiana, 71103, United States
Burnsville Minnesota, 55337, United States More Info
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Burnsville Minnesota, 55337, United States More Info
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Cambridge Minnesota, 55008, United States More Info
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Coon Rapids Minnesota, 55433, United States More Info
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Edina Minnesota, 55435, United States More Info
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Fridley Minnesota, 55432, United States More Info
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Maple Grove Minnesota, 55369, United States More Info
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Maplewood Minnesota, 55109, United States More Info
Principal Investigator
Maplewood Minnesota, 55109, United States More Info
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Minneapolis Minnesota, 55407, United States More Info
Principal Investigator
Minneapolis Minnesota, 55415, United States More Info
Principal Investigator
Minneapolis Minnesota, 55454, United States More Info
Principal Investigator
Monticello Minnesota, 55362, United States More Info
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New Ulm Minnesota, 56073, United States More Info
Principal Investigator
Princeton Minnesota, 55371, United States More Info
Principal Investigator
Robbinsdale Minnesota, 55422, United States More Info
Principal Investigator
Saint Louis Park Minnesota, 55416, United States More Info
Principal Investigator
Saint Paul Minnesota, 55101, United States More Info
Principal Investigator
Saint Paul Minnesota, 55102, United States More Info
Principal Investigator
Shakopee Minnesota, 55379, United States More Info
Principal Investigator
Stillwater Minnesota, 55082, United States More Info
Principal Investigator
Waconia Minnesota, 55387, United States More Info
Principal Investigator
Willmar Minnesota, 56201, United States More Info
Principal Investigator
Woodbury Minnesota, 55125, United States More Info
Principal Investigator
Wyoming Minnesota, 55092, United States More Info
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Jackson Mississippi, 39216, United States More Info
Principal Investigator
Ballwin Missouri, 63011, United States More Info
Principal Investigator
Bolivar Missouri, 65613, United States
Branson Missouri, 65616, United States
Independence Missouri, 64057, United States
Joplin Missouri, 64804, United States More Info
Principal Investigator
Joplin Missouri, 64804, United States More Info
Principal Investigator
Kansas City Missouri, 64132, United States
Rolla Missouri, 65401, United States More Info
Principal Investigator
Rolla Missouri, 65401, United States More Info
Principal Investigator
Saint Joseph Missouri, 64506, United States More Info
Principal Investigator
Saint Louis Missouri, 63109, United States More Info
Principal Investigator
Saint Louis Missouri, 63128, United States More Info
Principal Investigator
Saint Louis Missouri, 63141, United States More Info
Principal Investigator
Springfield Missouri, 65804, United States More Info
Principal Investigator
Springfield Missouri, 65807, United States More Info
Principal Investigator
Washington Missouri, 63090, United States More Info
Principal Investigator
Anaconda Montana, 59711, United States More Info
Principal Investigator
Billings Montana, 59101, United States More Info
Principal Investigator
Bozeman Montana, 59715, United States More Info
Principal Investigator
Great Falls Montana, 59405, United States More Info
Principal Investigator
Great Falls Montana, 59405, United States More Info
Principal Investigator
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States More Info
Principal Investigator
Missoula Montana, 59804, United States More Info
Principal Investigator
New York New York, 10032, United States More Info
Principal Investigator
Oklahoma City Oklahoma, 73120, United States More Info
Principal Investigator
Baker City Oregon, 97814, United States More Info
Principal Investigator
Ontario Oregon, 97914, United States More Info
Principal Investigator
Portland Oregon, 97227, United States
Boiling Springs South Carolina, 29316, United States
Easley South Carolina, 29640, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Greer South Carolina, 29650, United States
Seneca South Carolina, 29672, United States
Houston Texas, 77030, United States More Info
Principal Investigator
Seattle Washington, 98112, United States
New Richmond Wisconsin, 54017, United States More Info
Principal Investigator
Cody Wyoming, 82414, United States More Info
Principal Investigator
Sheridan Wyoming, 82801, United States More Info
Principal Investigator
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