UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051975 |
|---|---|
| Receipt number | R000059238 |
| Scientific Title | Optimal therapeutic strategies with CDK4/6 inhibitors based on the real world evidence in patients with HR-positive/HER2-negative advanced and metastatic breast cancer |
| Date of disclosure of the study information | 2023/08/25 |
| Last modified on | 2024/03/21 17:41:36 |
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Basic information
Public title
Optimal therapeutic strategies with CDK4/6 inhibitors based on the real world evidence in patients with HR-positive/HER2-negative advanced and metastatic breast cancer
Acronym
JBCRG-C10
Scientific Title
Optimal therapeutic strategies with CDK4/6 inhibitors based on the real world evidence in patients with HR-positive/HER2-negative advanced and metastatic breast cancer
Scientific Title:Acronym
JBCRG-C10
Region
| Japan |
Condition
Condition
Hormone receptor positive HER2 negative advanced metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to generate real-world evidence in Japan on the actual treatment of patients with hormone receptor-positive HER2-negative advanced metastatic breast cancer treated with CDK4/6 inhibitors (palbociclib or abemaciclib) as primary or second-line therapy.
Basic objectives2
Others
Basic objectives -Others
Chemotherapy-free survival (CFS)
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Chemotherapy-free survival (CFS)
Key secondary outcomes
1.Overall survival: OS
2.CFS
3.real world progression-free survival: rwPFS
4. Time to treatment discontinuation : TTD
5. Background factors for CDK4/6 inhibitors + endocrine therapy
6. CDK4/6 inhibitor + endocrine therapy post-treatment TTD
7. Exploratory study: prediction factors of response to CDK4/6 inhibitor + endocrine therapy
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
Female
Key inclusion criteria
1)Women over 18 years old
2)Menopausal status is not required
3)Diagnosed with advanced metastatic breast cancer (AMBC)
4)Confirmed estrogen receptor (ER) positive or progesterone receptor (PgR) positive
5)Confirmed HER2 negative
6)Palbociclib (PAL) or abemaciclib (ABE) initiated in combination with any endocrine therapy as primary or secondary treatment for AMBC between January 1, 2019 and December 31, 2021
7)PAL or ABE administered for at least 2 months
8)No anticancer therapy prior to initiation of PAL or ABE as AMBC treatment
9)If PAL or ABE was used as perioperative treatment, the period from the date of its last administration to the date of AMBC diagnosis is at least 6 months
10)Has not expressed non-participation in the study
Key exclusion criteria
non
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiro |
| Middle name | |
| Last name | Yoshinami |
Organization
Osaka University Hospital
Division name
Breast and Endocrine Surgery
Zip code
565-0871
Address
2-2-E10 Yamadaoka, Suita Osaka
TEL
06-6879-3772
t2hr_y@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Fukase |
Organization
Japan Breast Cancer Research Group(JBCRG)
Division name
Head office
Zip code
103-0016
Address
9-4-3F,Nihonbashi koamicho,Chuo-ku,Tokyo 103-0016, Japan
TEL
03-6264-8873
Homepage URL
https://www.jbcrg.jp/
office@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group(JBCRG)
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Osaka University Hospital
Address
Yamadaoka 2-2, Suita, Osaka, Japan.
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
大阪大学医学部附属病院（大阪府）/ Osaka University Hospital（Osaka）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-A multi-institutional observational study using real world data (RWD) to clarify the current status of CDK4/6 inhibitor therapy in Japan.
-The primary endpoint is chemotherapy-free survival (CFS) from the start of primary treatment.
-Evaluate CFS by timing of initial CDK4/6 inhibitor use and post-treatment patterns
-Secondary endpoints include overall survival from AMBC diagnosis, CDK4/6 inhibitor + background factors for endocrine therapy
-Collaborating institutions collect information on predetermined items from electronic medical records and enter it into the EDC.
-The research secretariat and data center will be handled by General Incorporated Association JBCRG (hereafter referred to as JBCRG).
-This research was conducted in collaboration with Eli Lilly Japan and is funded by Eli Lilly Japan to the JBCRG. The company does not access or analyze the collected data.
-The collaborating institutions will be approximately 40 facilities nationwide with full-time breast specialists and oncology pharmacotherapy specialists or equivalent.
Management information
Registered date
| 2023 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059238
