UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046611 |
|---|---|
| Receipt number | R000053171 |
| Scientific Title | Evaluation of association of HLA and ABCG2 alleles with Severe interstitial lung disease (ILD) and hepatotoxicity in patients receiving abemaciclib |
| Date of disclosure of the study information | 2022/01/14 |
| Last modified on | 2026/02/11 18:50:04 |
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Basic information
Public title
Evaluation of association of HLA and ABCG2 alleles with Severe interstitial lung disease (ILD) and hepatotoxicity in patients receiving abemaciclib
Acronym
Evaluation of association of HLA and ABCG2 alleles with ILD and hepatotoxicity in patients receiving abemaciclib
Scientific Title
Evaluation of association of HLA and ABCG2 alleles with Severe interstitial lung disease (ILD) and hepatotoxicity in patients receiving abemaciclib
Scientific Title:Acronym
Evaluation of association of HLA and ABCG2 alleles with ILD and hepatotoxicity in patients receiving abemaciclib
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the association of HLA and ABCG2 alleles with ILD and hepatotoxicity in patients receiving abemaciclib.
Basic objectives2
Others
Basic objectives -Others
To explore risk factors
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the association of HLA and ABCG2 alleles with abemaciclib-induced ILD
Key secondary outcomes
To assess the association of HLA and ABCG2 alleles with abemaciclib-induced hepatotoxicity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients for the secondary research in the nested case control study of abemaciclib-induced interstitial lung disease (NOSIDE).
Key exclusion criteria
Not specified
Target sample size
236
Research contact person
Name of lead principal investigator
| 1st name | Chiyo |
| Middle name | K. |
| Last name | IMAMURA |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8145
imamurack@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Chiyo |
| Middle name | K. |
| Last name | IMAMURA |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8145
Homepage URL
imamurack@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
CSPOR-BC
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
昭和大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
not released
Publication of results
Published
Result
URL related to results and publications
https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3087
Number of participants that the trial has enrolled
83
Results
There was no significant association between HLA alleles and development of ILD. On the other hand, HLA-DPB1*05:01, HLA-DQA1*05:05 and HLA-A*31:01 were found to be significantly associated with ALT elevation of grade 2/3. ABCG2 genotypes were not associated with ILD and hepatotoxicity.
Results date posted
| 2026 | Year | 02 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients for the secondary research in the nested case control study of abemaciclib-induced interstitial lung disease (NOSIDE).
Participant flow
Of 236 abemaciclib-treated patients with advanced breast cancer in the NOSIDE study, 83 patients were enrolled by obtaining additional informed consent for collecting blood and pharmacogenetic investigation.
Adverse events
N/A
Outcome measures
There was no significant association between HLA alleles and development of ILD. On the other hand, HLA-DPB1*05:01, HLA-DQA1*05:05 and HLA-A*31:01 were found to be significantly associated with ALT elevation of grade 2/3. ABCG2 genotypes were not associated with ILD and hepatotoxicity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
Case-control study
Management information
Registered date
| 2022 | Year | 01 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053171
