Recruiting
Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
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.
ClinicalTrials.gov IDNCT05731258
PhaseNot Applicable
Enrollment150
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer, Liposomal Doxorubicin, Efficacy, Safety, Postoperative Adjuvant Treatment
About this study
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
- Drug: Liposomal doxorubicin containing regimen — Liposomal doxorubicin hydrochloride (PLD) 30-40mg/m2 D1 + other drugs (decided by investigators); All patients were treated with 4 cycles.
Primary outcomes
- Cardiac safety (10 years)
Eligibility information
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.
Study locations
- Second Affiliate Hospital of Zhejiang University, Hangzhou, Zhejiang 310009 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.