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Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
NCT05731258 · Second Affiliated Hospital, School of Medicine, Zhejiang University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
About this study
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 caused by the disease or with a history of significant mental disorders and central nervous system disorders;
4. Those with severe infection or active peptic ulcer requiring treatment;
5. Allergic to chemotherapy drugs;
6. Cancer free period less than 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;
7. Severe liver disease (e.g., cirrhosis, etc.), renal disease, respiratory disease, or uncontrolled diabetes;
8. Patients who are participating in other clinical trials or within a month.
Study design
Enrollment target: 150 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-05-01
Estimated completion: 2032-10
Last updated: 2023-02-16
Interventions
Drug: Liposomal doxorubicin containing regimen
Primary outcomes
- • Cardiac safety (10 years)
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University · other
Contacts & investigators
ContactXiaochen Wang, Dr. · contact · wangxiaochen@zju.edu.cn · +86 13958161286
ContactShizhen Zhang, Dr. · contact · zhangshizhen@zju.edu.cn · +86 15168338547
All locations (1)
Second Affiliate Hospital of Zhejiang UniversityRecruiting
Hangzhou, Zhejiang, China