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NCT05731258
Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
Conditions: Breast Cancer, Liposomal Doxorubicin, Efficacy, Safety, Postoperative Adjuvant Treatment
Sex: Female
Ages: 18 Years – 75 Years
Enrollment: 150
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Location: China
Summary
The goal of this observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients.
Eligibility Criteria
Inclusion Criteria:Female, aged 18-75 years;Primary breast cancer diagnosed histopathologically;Adjuvant chemotherapy regimens include liposomal doxorubicin;ECoG PS score: 0-1 points;Left ventricular ejection fraction (LVEF) ≥ 55%;Estimated survival ≥ 6 months;Major organ function is normal, i.e. meets the following criteria:① And white blood cells ≥ 4.0 × 10 9 / L, neutrophil count (ANC) ≥ 1.5 × 10 9 /L;② Platelets ≥ 100 × 10 9 /L;③ And hemoglobin ≥ 10 g / dl; ④ Serum creatinine ≤ 1.5 × ⑤ the upper limit of normal (ULN) Mmol / L and aspartate transaminase (AST) ≤ 2.5× ULN;⑥ Alanine transaminase (ALT) ≤ 2.5 × ULN;⑦ Total bilirubin ≤ 1.5 × ULN;⑧ Serum creatinine ≤ 1.5 × ULN;Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up.Exclusion Criteria:Pregnant, lactating patients;Breast cancer has been found to have distant metastasis;Those with peripheral nervous system disorders caused by the disease or with a history of significant mental disorders and central nervous system disorders;Those with severe infection or active peptic ulcer requiring treatment;Allergic to chemotherapy drugs;Cancer free period less than 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;Severe liver disease (e.g., cirrhosis, etc.), renal disease, respiratory disease, or uncontrolled diabetes;Patients who are participating in other clinical trials or within a month.
Source: ClinicalTrials.gov (NCT05731258). StuddyBuddy aggregates publicly available trial information.