Clinical trial · Observational
Biomarkers of Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients
Biomarkers Study of Liposomal Doxorubicin Injection Induced Hypersensitivity Reaction in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hypersensitivity reaction group
- description
- The patients get hypersensitivity after Pegylated liposomal doxorubicin injection.
- interventionNames
- Other: Blood sampling
- label
- None hypersensitivity reaction group
- description
- The patients do not get hypersensitivity after Pegylated liposomal doxorubicin injection.
- interventionNames
- Other: Blood sampling
Primary outcomes (1)
- measure
- The predictive biomarkers of PLD induced hypersensitivity
- timeFrame
- 2022.06-2023.12
- description
- Detect and analyze the association between hypersensitivity and metabonomics, anti-PEG antibody, IgE et. al
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDAlberts DS, Garcia DJ. Safety aspects of pegylated liposomal doxorubicin in patients with cancer. Drugs. 1997;54 Suppl 4:30-5. doi: 10.2165/00003495-199700544-00007. PMID 9361959
- BACKGROUNDCastells MC, Tennant NM, Sloane DE, Hsu FI, Barrett NA, Hong DI, Laidlaw TM, Legere HJ, Nallamshetty SN, Palis RI, Rao JJ, Berlin ST, Campos SM, Matulonis UA. Hypersensitivity reactions to chemotherapy: outcomes and safety of rapid desensitization in 413 cases. J Allergy Clin Immunol. 2008 Sep;122(3):574-80. doi: 10.1016/j.jaci.2008.02.044. Epub 2008 May 27. PMID 18502492
- BACKGROUNDChen E, Chen BM, Su YC, Chang YC, Cheng TL, Barenholz Y, Roffler SR. Premature Drug Release from Polyethylene Glycol (PEG)-Coated Liposomal Doxorubicin via Formation of the Membrane Attack Complex. ACS Nano. 2020 Jul 28;14(7):7808-7822. doi: 10.1021/acsnano.9b07218. Epub 2020 Mar 6. PMID 32142248
- BACKGROUNDGabizon A, Szebeni J. Complement Activation: A Potential Threat on the Safety of Poly(ethylene glycol)-Coated Nanomedicines. ACS Nano. 2020 Jul 28;14(7):7682-7688. doi: 10.1021/acsnano.0c03648. Epub 2020 Jul 9. PMID 32643376
- BACKGROUNDVerhoef JJ, Carpenter JF, Anchordoquy TJ, Schellekens H. Potential induction of anti-PEG antibodies and complement activation toward PEGylated therapeutics. Drug Discov Today. 2014 Dec;19(12):1945-52. doi: 10.1016/j.drudis.2014.08.015. Epub 2014 Sep 7. PMID 25205349