Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

Breast Cancer Clinical Trial

Official title:

Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731258
• Other study ID #: 2022-0239
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: October 2032

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiaochen Wang, Dr.
• Phone: +86 13958161286
• Email: wangxiaochen[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2032
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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:

? And white blood cells = 4.0 × 10 9 / L, neutrophil count (ANC) = 1.5 × 10 9 /L;? Platelets = 100 × 10 9 /L;? And hemoglobin = 10 g / dl; ? Serum creatinine = 1.5 × ? the upper limit of normal (ULN) Mmol / L and aspartate transaminase (AST) = 2.5

× ULN;? Alanine transaminase (ALT) = 2.5 × ULN;? Total bilirubin = 1.5 × ULN;? 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Efficacy
• Safety

Intervention

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.

Locations

Country	Name	City	State
China	Second Affiliate Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac safety	Cardiac ejection fraction	10 years
Secondary	Overall survival		10 years