Biomarkers of Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients

• Conditions: Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients
• Interventions: Other: Blood sampling

• Registration Number: NCT05181202
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

Pegylated liposomal doxorubicin (PLD) was an anthracycline nanomedicine to be approved for advanced breast cancer and other solid tumor therapy and showed a good disease control rate (57%). PLD could induce hypersensitivity reaction (HSR). There are about 9-25% patients got infusion reaction or HSR. Severe HSR could lead to allergic shock even presyncope or threat to life. To our knowledge, there were no sensitivity biomarker to predict the PLD induced HSR. And the mechanism of PLD induced HSR is unknown yet. Therefore, to analyze and discuss the biomarkers and mechanism of PLD induced HSR in advanced breast cancer, we design this prospective, observational, biomarker study.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-07
• Status Verified: 2021-12
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Last Update Submitted: 2021-12-21
• Study First Posted: 2022-01-06
• Last Update Posted: 2022-01-06
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• ≥18 years old; Breast cancer confirmed with histological or molecular diagnosis; Advanced breast cancer diagnosis according to American Joint Committee on cancer eighth edition cancer staging manual; Treatment with liposomal doxorubicin; No pregnancy plan and voluntary use of effective contraceptive measures during treatment

Exclusion Criteria

• Subjects who discontinued treatment due to previous severe adverse reactions to liposomal doxorubicin or doxorubicin; poor compliance.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypersensitivity reaction group	Blood sampling	The patients get hypersensitivity after Pegylated liposomal doxorubicin injection.
None hypersensitivity reaction group	Blood sampling	The patients do not get hypersensitivity after Pegylated liposomal doxorubicin injection.

Primary Outcome Measures

Name	Time	Method
The predictive biomarkers of PLD induced hypersensitivity	2022.06-2023.12	Detect and analyze the association between hypersensitivity and metabonomics, anti-PEG antibody, IgE et. al

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China