Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Cardiac safety [10 years]
Cardiac ejection fraction
Secondary Outcome Measures
- Overall survival [10 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female, aged 18-75 years;
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Primary breast cancer diagnosed histopathologically;
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Adjuvant chemotherapy regimens include liposomal doxorubicin;
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ECoG PS score: 0-1 points;
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Left ventricular ejection fraction (LVEF) ≥ 55%;
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Estimated survival ≥ 6 months;
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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:
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Pregnant, lactating patients;
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Breast cancer has been found to have distant metastasis;
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Those with peripheral nervous system disorders caused by the disease or with a history of significant mental disorders and central nervous system disorders;
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Those with severe infection or active peptic ulcer requiring treatment;
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Allergic to chemotherapy drugs;
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Cancer free period less than 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;
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Severe liver disease (e.g., cirrhosis, etc.), renal disease, respiratory disease, or uncontrolled diabetes;
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Patients who are participating in other clinical trials or within a month.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Second Affiliate Hospital of Zhejiang University | Hangzhou | Zhejiang | China | 310009 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-0239