UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058459 |
|---|---|
| Receipt number | R000066847 |
| Scientific Title | Comparison of the Effectiveness of CDK4/6 Inhibitors as First-Line or Later-Line Therapy for Hormone Receptor-Positive, HER2-Negative Metastatic Recurrent Breast Cancer |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/14 15:34:03 |
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Basic information
Public title
Comparison of the Effectiveness of CDK4/6 Inhibitors as First-Line or Later-Line Therapy for Hormone Receptor-Positive, HER2-Negative Metastatic Recurrent Breast Cancer
Acronym
Comparison of the Effectiveness of CDK4/6 Inhibitors as First-Line or Later-Line Therapy for Hormone Receptor-Positive, HER2-Negative Metastatic Recurrent Breast Cancer
Scientific Title
Comparison of the Effectiveness of CDK4/6 Inhibitors as First-Line or Later-Line Therapy for Hormone Receptor-Positive, HER2-Negative Metastatic Recurrent Breast Cancer
Scientific Title:Acronym
Comparison of the Effectiveness of CDK4/6 Inhibitors as First-Line or Later-Line Therapy for Hormone Receptor-Positive, HER2-Negative Metastatic Recurrent Breast Cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By evaluating the effectiveness of one or two reimbursed CDK4/6 inhibitors, as well as treatments administered before and after their use, this study aims to provide evidence that could greatly contribute to treatment decision-making for patients with hormone receptor-positive, HER2-negative metastatic or recurrent breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of treatment efficacy of one or two CDK4/6 inhibitors based on RECIST version 1.1
Key secondary outcomes
Overall Survival (OS):Defined as the time from the date of diagnosis of metastasis or recurrence to the date of death from any cause.
Progression-Free Survival (PFS):Defined as the time from the initiation of CDK4/6 inhibitor therapy to the earliest of the following events: disease progression, death, or discontinuation of treatment due to adverse events.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients with hormone receptor-positive, HER2-negative metastatic or recurrent breast cancer who received treatment with a single CDK4/6 inhibitor (palbociclib or abemaciclib) between March 1, 2018 and November 30, 2019.
2.Patients with hormone receptor-positive, HER2-negative metastatic or recurrent breast cancer who received two different CDK4/6 inhibitors at different treatment timings between March 1, 2018 and November 30, 2019.
Key exclusion criteria
None
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Goi |
Organization
University of Fukui Hospital
Division name
Department of Gastrointestinal, Breast and Endocrine Surgery
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776-61-8375
tgoi@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Goi |
Organization
University of Fukui Hospital
Division name
Department of Gastrointestinal, Breast and Endocrine Surgery
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776-61-8375
Homepage URL
tgoi@u-fukui.ac.jp
Sponsor or person
Institute
Fukui University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Kyorin Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Fukui Hospital
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji-cho, Yoshida-gun, Fukui, Japan
Tel
0776-61-8375
tgoi@u-fukui.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 15 | 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
66
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter, retrospective cohort observational study conducted in Japan.
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066847
