Biomarkers of Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients
NCT ID: NCT05181202
Last Updated: 2022-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
20 participants
OBSERVATIONAL
2021-02-07
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Marched Pair Study Conventional Doxorubicin(DOX) Versus Pegylated Liposomal Doxorubicin(PLD) Neoadjuvant Chemotherapy
NCT02953184
A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer
NCT03017404
Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection (Lipodox®) in Chinese Patients
NCT05273944
RWS of Paclitaxel Liposome Combined With Anti-HER-2 Monoclonal Antibody
NCT06481553
SHR-1210 Combined With Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for Triple Negative Breast Cancer
NCT04213898
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hypersensitivity reaction group
The patients get hypersensitivity after Pegylated liposomal doxorubicin injection.
Blood sampling
Collect blood before drug injection. we do not intervene the clinical administration or drug choice or other clinical treatment.
None hypersensitivity reaction group
The patients do not get hypersensitivity after Pegylated liposomal doxorubicin injection.
Blood sampling
Collect blood before drug injection. we do not intervene the clinical administration or drug choice or other clinical treatment.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood sampling
Collect blood before drug injection. we do not intervene the clinical administration or drug choice or other clinical treatment.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Suiwen Ye
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Alberts 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.
Castells 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.
Chen 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.
Gabizon 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.
Verhoef 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.
Related Links
Access external resources that provide additional context or updates about the study.
breast cancer epidemiology
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YDPLD191016-I1-SYSU-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.