Biomarkers of Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients

Biomarkers Study of Liposomal Doxorubicin Injection Induced Hypersensitivity Reaction in Breast Cancer Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05181202

Enrollment

Registered

2022-01-06

Start date

2021-02-07

Completion date

2023-06-30

Last updated

2022-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients

Keywords

liposomal doxorubicin, hypersensitivity reaction, breast cancer

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.

Interventions

OTHERBlood sampling

Collect blood before drug injection. we do not intervene the clinical administration or drug choice or other clinical treatment.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactWei Zhuang, Dr.

zhuangw8@mail.sysu.edu.cn+86-13427526343

Backup ContactSuiwen Ye

+86-13825115916

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026