Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

Zhejiang University

Status: Enrolling

Conditions: Breast Cancer; Efficacy; Liposomal Doxorubicin; Postoperative Adjuvant Treatment; Safety

Treatments: Drug: Liposomal doxorubicin containing regimen

Study type: Observational

Funder types: Other

Identifiers

NCT05731258

2022-0239

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.