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Recruiting NCT05731258

Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

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Trial Parameters

Condition Breast Cancer
Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 150
Sex FEMALE
Min Age 18 Years
Max Age 75 Years
Start Date 2022-05-01
Completion 2027-10
Interventions
Liposomal doxorubicin containing regimen

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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.

Eligibility Criteria

Inclusion Criteria: 1. Female, aged 18-75 years; 2. Primary breast cancer diagnosed histopathologically; 3. Adjuvant chemotherapy regimens include liposomal doxorubicin; 4. ECoG PS score: 0-1 points; 5. Left ventricular ejection fraction (LVEF) ≥ 55%; 6. Estimated survival ≥ 6 months; 7. 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; 8. Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up. Exclusion Criteria: 1. Pregnant, lactating patients; 2. Breast cancer has been found to have distant metastasis; 3. Those with peripheral nervous system disorders

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