RecruitingNCT05731258

Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

150 participants

Start Date

May 1, 2022

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Efficacy Liposomal Doxorubicin Safety Postoperative Adjuvant Treatment

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria10

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 Criteria8

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.