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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country150 target enrollmentMay 1, 2022

ConditionsBreast Cancer Liposomal Doxorubicin Efficacy Safety Postoperative Adjuvant Treatment

DrugsLiposomal doxorubicin containing regimen

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 150
Locations: 1
Primary Endpoint: Cardiac safety
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 1, 2022

End Date

October 2032

Last Updated

3 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Sponsor

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.