NCT05181202

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
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients

Interventions

Type	Name	Description
OTHER	Blood sampling	Collect blood before drug injection. we do not intervene the clinical administration or drug choice or other clinical treatment.

Timeline

• Start date: 2021-02-07
• Primary completion: 2022-12-31
• Completion: 2023-06-30
• First posted: 2022-01-06
• Last updated: 2022-01-06

Locations

1 site across 1 country: China