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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal doxorubicin containing regimen | Drug | Liposomal doxorubicin hydrochloride (PLD) 30-40mg/m2 D1 + other drugs (decided by investigators); All patients were treated with 4 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac safety | Cardiac ejection fraction | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 10 years |
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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:
①And 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:
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Early breast cancer patients who required four cycles of chemotherapy after curative resection of breast cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaochen Wang, Dr. | Contact | +86 13958161286 | wangxiaochen@zju.edu.cn | |
| Shizhen Zhang, Dr. | Contact | +86 15168338547 | zhangshizhen@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliate Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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