Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

Recruiting

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

• Registration Number: NCT05731258
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16
• Primary Completion: 2027-10
• Study Completion: 2032-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac safety	10 years	Cardiac ejection fraction

Secondary Outcome Measures

Name	Time	Method
Overall survival	10 years

Trial Locations

Locations (1)

Second Affiliate Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China