Breast Cancer, Efficacy, Liposomal Doxorubicin, Postoperative Adjuvant Treatment, Safety
Conditions
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.
Interventions
DRUGLiposomal doxorubicin containing regimen
Liposomal doxorubicin hydrochloride (PLD) 30-40mg/m2 D1 + other drugs (decided by investigators); All patients were treated with 4 cycles.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac safety | 10 years | Cardiac ejection fraction |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 10 years |
Countries
China
Contacts
Primary ContactXiaochen Wang, Dr.
Backup ContactShizhen Zhang, Dr.
Outcome results
None listed