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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

Study Start

First participant enrolled

February 7, 2021

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2021

Completed

16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed

Last Updated

January 6, 2022

Status Verified

December 1, 2021

Enrollment Period

1.9 years

First QC Date

December 21, 2021

Last Update Submit

December 21, 2021

Conditions

Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients

Keywords

liposomal doxorubicinhypersensitivity reactionbreast cancer

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

Hypersensitivity reaction group

The patients get hypersensitivity after Pegylated liposomal doxorubicin injection.

Other: Blood sampling

None hypersensitivity reaction group

The patients do not get hypersensitivity after Pegylated liposomal doxorubicin injection.

Other: Blood sampling

Interventions

Blood samplingOTHER

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

Hypersensitivity reaction groupNone hypersensitivity reaction group

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Advanced breast cancer patients who recieve liposomal doxorubicin treatment.

You may qualify if:

≥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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitylead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (5)

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.
PMID: 9361959BACKGROUND
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.
PMID: 18502492BACKGROUND
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.
PMID: 32142248BACKGROUND
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.
PMID: 32643376BACKGROUND
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.
PMID: 25205349BACKGROUND

MeSH Terms

Conditions

HypersensitivityBreast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Wei Zhuang, Dr.

CONTACT

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

Suiwen Ye

CONTACT

+86-13825115916

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 1 Week
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 6, 2022

Study Start

February 7, 2021

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

January 6, 2022

Record last verified: 2021-12

Locations

CN(1)

Biomarkers of Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Hypersensitivity reaction group

None hypersensitivity reaction group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Hypersensitivity reaction group

None hypersensitivity reaction group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Locations