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Study on the Antiviral Efficacy and Safety of Nucleoside (Nucleotide) Analogues in Breast Cancer Patients with Chronic HBV Infection Undergoing Chemotherapy

Study on the Antiviral Efficacy and Safety of Nucleoside (Nucleotide) Analogues in Breast Cancer Patients with Chronic HBV Infection Undergoing Chemotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101378
Enrollment
Unknown
Registered
2025-04-24
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B virus reactivation

Interventions

Entecavir group:Administration of Entecavir
Tenofovir fumarate group:Administration of Tenofovir disoproxil fumarate
Tenofovir alafenamide group:Administration of Tenofovir alafenamide

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Female patients aged over 18 and under 70 years; (2) Positive for HBsAg as indicated by hepatitis B surface antigen test (HBV two-phase test); (3) Histologically diagnosed breast cancer, with indications for adjuvant chemotherapy or neoadjuvant chemotherapy; (4) Subjects voluntarily participate in this study, sign informed consent, have good compliance, and cooperate with follow-up.

Exclusion criteria

Exclusion criteria: (1) Creatinine clearance was less than 50ml/min, ALT or AST was 10 times higher than the upper limit of normal, white blood cells <=3.5*10^9/L, platelets <=75*10^9/L, hemoglobin less than 10g/dl, albumin less than 3g/dl, total bilirubin greater than 2.5 times the upper limit of normal, The INR is 1.5 times greater than the upper limit of normal. (2) signs of decompensation of cirrhosis (Child-Pugh score B, C) or complicating hepatocellular carcinoma, alcoholic liver disease, autoimmune liver disease, hereditary liver disease, HIV, hepatitis C virus or hepatitis D virus infection; (3) Received chemotherapy or antiviral treatment within the last 1 year; (4) Pregnant and lactating women or those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; (5) Patients who have not completed the established chemotherapy regimen or whose data is incomplete; (6) Patients who are not willing to accept the trial.

Design outcomes

Primary

MeasureTime frame
Hepatitis B virus DNA;C-reactive protein;Dilution and quantification of hepatitis B surface antigen;ß 2-microglobulin (urine);ß 2-microglobulin (blood);Determination of urinary a1 microglobulin;Osteocalcin;Special sequences of ß -collagen;Total type I collagen amino-terminal prolonging peptide;Cystatin;Ferritin;25-hydroxyvitamin D;Parathyroid hormone;Color Doppler ultrasound elastography of the liver;Total bilirubin;Direct bilirubin;Total protein;Albumin;Prealbumin;Alanine aminotransferase;Aspartate aminotransferase;Alkaline phosphatase;? -glutamyl aminotransferase;Cholinesterase;Total bile acid;Urea;Serum creatinine;Blood uric acid;Glucose;

Secondary

MeasureTime frame
Insulin (fasting);Glycosylated hemoglobin;

Countries

China

Contacts

Public ContactLi Dan

Fujian Medical University Union Hospital

doctorlidan99@fjmu.edu.cn+86 136 6591 0161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026