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 | 2025/09/19 18:01:18 |
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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/
JBCRG-QAG@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）
名古屋大学医学部附属病院（愛知県）
社会医療法人博愛会相良病院（鹿児島県）
広島市立広島市民病院（広島県）
独立行政法人国立病院機構北海道がんセンター（北海道）
埼玉県立がんセンター（埼玉県）
がん研究会有明病院（東京都）
地方独立行政法人大阪府立病院機構大阪国際がんセンター（大阪府）
熊本大学病院（熊本県）
独立行政法人国立病院機構四国がんセンター（愛媛県）
青森県立中央病院（青森県）
日本赤十字社愛知医療センター名古屋第一病院（愛知県）
日本赤十字社愛知医療センター名古屋第二病院（愛知県）
浜松医科大学医学部附属病院（静岡県）
富山大学附属病院（富山県）
兵庫県立尼崎総合医療センター（兵庫県）
北海道大学病院（北海道）
金沢医科大学（石川県）
市立貝塚病院（大阪府）
独立行政法人国立病院機構九州がんセンター（福岡県）
八尾市立病院（大阪府）
筑波大学附属病院（茨城県）
社会医療法人神鋼記念会神鋼記念病院（兵庫県）
市立四日市病院（三重県）
北里大学病院（神奈川県）
東北大学病院（宮城県）
愛媛大学医学部附属病院（愛媛県）
関西医科大学附属病院（大阪府）
岐阜大学医学部附属病院（岐阜県）
京都府立医科大学附属病院（京都府）
群馬県立がんセンター（群馬県）
群馬大学医学部附属病院（群馬県）
県立広島病院（広島県）
国立研究開発法人国立国際医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12282-025-01713-7
Number of participants that the trial has enrolled
808
Results
Conclusions
The real-world survival outcomes found in this study for patients receiving first-/second-line CDK4/6i therapy were consistent with those of randomized phase 3 studies. As outcomes of subsequent treatment after initial CDK4/6i plus ET remain insufficient, further improvement in treatment is necessary.
Results date posted
| 2025 | Year | 09 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 05 | Month | 20 | Day |
Baseline Characteristics
Patients who had started CDK4/6i therapy between January 1, 2019, and December 31, 2021, as first-/second-line treatment for AMBC were used
Participant flow
A total of 808 patients with AMBC were registered. After exclusion of 63 patients, the FAS comprised data from 745 patients, of whom 533 and 212 received CDK4/6i therapy as first-line treatment and second-line treatment for AMBC, respectively (Fig. 1). Of the 212 patients who received CDK4/6i therapy as second-line treatment, 112 (52.8%) had been treated with an AI +- luteinizing hormone releasing hormone analog (LHRHa), 53 (25.0%) with fulvestrant +- LHRHa, 45 (21.2%) with a selective estrogen receptor modulator +- LHRHa, and 2 (0.9%) with other treatments. The median follow-up was 32.5 (range 2.5-101.0) months.
Adverse events
Adverse event data were not collected.
Outcome measures
Results
Data from 745 patients were analyzed. Compared with palbociclib, abemaciclib was used in younger patients and those with expected poor prognosis. Median rwPFS was 36.8, 17.8, and 31.4 months in patients with de novo stage IV disease, TFI < 12 months, and TFI >= 12 months, respectively, in the first-line treatment group, and 17.4 months in the second-line treatment group. In the exclusive first-line treatment group, median rwPFS of the subsequent treatment after initial CDK4/6i plus ET was < 7 months, regardless of the type of subsequent treatment; prognosis was especially poor in those who were switched to chemotherapy.
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2027 | 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
| 2025 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059238
