UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059286 |
|---|---|
| Receipt number | R000067441 |
| Scientific Title | Pharmacokinetics/pharmacodynamics/genome pharmacology study of the antibody-drug conjugate Sacituzumab Govitecan: multi-institutional prospective observational trial |
| Date of disclosure of the study information | 2025/10/04 |
| Last modified on | 2025/10/04 09:38:52 |
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Basic information
Public title
Pharmacokinetics/pharmacodynamics/genome pharmacology study of the antibody-drug conjugate Sacituzumab Govitecan: multi-institutional prospective observational trial
Acronym
Pharmacokinetics/pharmacodynamics/genome pharmacology study of the antibody-drug conjugate Sacituzumab Govitecan: multi-institutional prospective observational trial
Scientific Title
Pharmacokinetics/pharmacodynamics/genome pharmacology study of the antibody-drug conjugate Sacituzumab Govitecan: multi-institutional prospective observational trial
Scientific Title:Acronym
Pharmacokinetics/pharmacodynamics/genome pharmacology study of the antibody-drug conjugate Sacituzumab Govitecan: multi-institutional prospective observational trial
Region
| Japan |
Condition
Condition
Triple Negative Breast Cancer (TNBC)
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate whether there are differences in the incidence of adverse events and drug blood concentrations between patients with unresectable or recurrent triple-negative breast cancer who received Sacituzumab Govitecan therapy and those with UGT1A1 gene polymorphisms compared to those with wild-type genotypes.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the correlation between UGT1A1 gene polymorphism and the incidence of grade 3 or higher neutropenia.
Key secondary outcomes
Evaluation of the correlation between drug blood concentration and adverse event incidence rate.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with inoperable or recurrent TNBC.
2. Patients aged 18 years or older scheduled to undergo SG therapy.
3. Patients who have provided written informed consent.
Key exclusion criteria
1. Patients who are pregnant or may be pregnant
2. Patients taking UGT1A1-inducing drugs (carbamazepine, phenytoin, rifampicin, phenobarbital)
3. Patients who have withdrawn their consent
4. Other cases deemed unsuitable by the physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisakazu |
| Middle name | |
| Last name | Ohtani |
Organization
Keio University
Division name
Department of Pharmacy, School of Medicine Hospital
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3706
Ohtani@keio.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kawazoe |
Organization
Keio University
Division name
Department of Clinical Pharmacy, Faculty of Pharmacy
Zip code
105-8512
Address
1-5-30 Shiba Park, Minato-ku, Tokyo, Japan
TEL
03-5400-2486
Homepage URL
kawazoe-ht@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）、京都大学医学部附属病院（京都府）、東京科学大学病院（東京都）、北海道がんセンター（北海道）、日本赤十字社医療センター（東京都）、けいゆう病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Observational Study in Collaboration with Other Institutions
Management information
Registered date
| 2025 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067441
