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Trial Title:
Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
NCT ID:
NCT05731258
Condition:
Breast Cancer
Liposomal Doxorubicin
Efficacy
Safety
Postoperative Adjuvant Treatment
Conditions: Official terms:
Breast Neoplasms
Doxorubicin
Liposomal doxorubicin
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Liposomal doxorubicin containing regimen
Description:
Liposomal doxorubicin hydrochloride (PLD) 30-40mg/m2 D1 + other drugs (decided by
investigators); All patients were treated with 4 cycles.
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.
Criteria for eligibility:
Study pop:
Early breast cancer patients who required four cycles of chemotherapy after curative
resection of breast cancer
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliate Hospital of Zhejiang University
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaochen Wang, Dr.
Phone:
+86 13958161286
Email:
wangxiaochen@zju.edu.cn
Contact backup:
Last name:
Shizhen Zhang, Dr.
Phone:
+86 15168338547
Email:
zhangshizhen@zju.edu.cn
Start date:
May 1, 2022
Completion date:
October 2032
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05731258
