臨床研究等提出・公開システム

Japanese

Date of registration	June. 03, 2025
Last modified on	June. 03, 2025
Trial ID	jRCT1070250028

Scientific Title	Retrospective Real-world Observational Study on Abemaciclib Plus Endocrine Therapy Versus Endocrine Monotherapy as First-Line Treatment in Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer (JBCRG-S04)
Public Title	JBCRG-S04 (JBCRG-S04)

Contact for Scientific Queries	Name	Yoshinami Tetsuhiro
	Affiliation	Osaka University Hospital
	Address	2-15 Yamadaoka, Suita Osaka
	Telephone	+81-6-6879-5111
	E-mail	t2hr_y@yahoo.co.jp
Contact for Public Queries	Name	Yoshinami Tetsuhiro
	Affiliation	Osaka University Hospital
	Address	2-15 Yamadaoka, Suita Osaka
	Telephone	+81-6-6879-5111
	E-mail	t2hr_y@yahoo.co.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		June. 03, 2025
Target sample size		750
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Eligible subjects enrolled in JBCRG-C10 (C10 Cohort) or ABCD Project (ABCD Cohort) Eligibility Criteria C10 Cohort: Subjects enrolled in JBCRG-C10 and meeting the following criteria: 1. ABE was initiated as first-line treatment* for AMBC in combination with an aromatase inhibitor (AI) or fulvestrant (FUL) as ET. Definition of first-line treatment: The first treatment after being diagnosed with AMBC. 2. No intention of refusal for secondary use of data. ABCD Cohort: Subjects enrolled in the ABCD project and meeting the following criteria: 1. Menopausal status is not considered. 2. Confirmed to be estrogen receptor (ER) positive (1% or more) or progesterone receptor (PgR) positive (1% or more). 3. Confirmed to be HER2 negative (Definition of HER2 negative: IHC 1+ or less, or FISH/DISH negative). 4. ABE was initiated as first-line treatment for AMBC in combination with AI or FUL as ET (ABE+ET combination group). Alternatively, AI or FUL as ET was initiated as first-line treatment (ET alone group). *Definition of first-line treatment: The first treatment after being diagnosed with AMBC. 5. In the case of the ET monotherapy group, ET was administered as first-line treatment for more than 2 months (in case of the comparative analysis with the C10 cohort). 6. If ABE was used as perioperative treatment, the period from the last administration date to the AMBC diagnosis date is 6 months or more. 7. Treatment was initiated on or after January 1, 2019. 8. No indication of refusal for secondary use of data.
	Exclusion Criteria	None
	Age Minimum	No limit
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		hormone receptor-positive, HER2-negative advanced metastatic breast cancer (AMBC)
Primary Outcome(s)		the Time to Next Treatment (TTNT) from the start of first-line treatment to the start of second-line treatment in the ABE+ET combination group of the C10 Cohort
Secondary Outcome(s)		Secondary endpoints include Chemotherapy Free Survival (CFS), which is the period until the start of chemotherapy, in the ABE+ET combination group of the C10 Cohort and the ABCD Cohort.

Primary Sponsor	Eli Lilly Japan K.K.

Name of Certified Review Board	Social Medical Corporation HAKUAIKAI Clinical Research Review Board
Address	3-31 Matsubara-cho, Kagoshima-city, KAGOSHIMA 892-0833 Japan, Kagoshima
Telephone	+81-99-224-1800
Approval Status	Approval
Date of approval	May. 14, 2025

Plan to share IPD	Yes
Plan description	In this study, the following observational items collected from the JBCRG-C10 and ABCD project will be used. 1 Data related to first-line treatment -Facility type -Age (date of birth), height, weight, PS, menopausal status, major medical history -Stage at initial diagnosis, period from initial diagnosis or initial surgery to recurrence diagnosis or start of first-line treatment, recurrence or De Novo -Metastasis sites (using data such as: presence or absence of visceral metastasis, bone-only metastasis or others, number of metastatic organs) -Start date of ABE administration, (C10 cohort only) initial dose of ABE -Type of ET, start date of ET -End date of first-line treatment, reason for termination (e.g., disease progression) 2 Data related to second-line treatment -Start date of second-line treatment -Type of second-line treatment (drug name) -End date of second-line treatment, reason for termination (e.g., disease progression) 3 Data related to chemotherapy -Start date of the first chemotherapy used for AMBC -First chemotherapy used for AMBC (drug name) 4 Data collected regardless of time point 1. Pathological findings -Histological type, Histological grade (or nuclear grade), ER/PgR expression status (IHC staining percentage or Allred score), HER2 expression status (IHC score or ISH determination) 2. Surgery/perioperative treatment -Surgery (surgery date), perioperative drug therapy (drugs used, start date, end date) -AMBC diagnosis date 3. Subsequent treatment -For the ET monotherapy group, whether CDK4/6 inhibitors were used in subsequent treatment -Drugs used (both ABE+ET and ET) 4. Outcome -Outcome (if died, whether it was due to the primary disease), date of outcome confirmation

Plan to share IPD

Yes

Plan description

In this study, the following observational items collected from the JBCRG-C10 and ABCD project will be used. 1 Data related to first-line treatment -Facility type -Age (date of birth), height, weight, PS, menopausal status, major medical history -Stage at initial diagnosis, period from initial diagnosis or initial surgery to recurrence diagnosis or start of first-line treatment, recurrence or De Novo -Metastasis sites (using data such as: presence or absence of visceral metastasis, bone-only metastasis or others, number of metastatic organs) -Start date of ABE administration, (C10 cohort only) initial dose of ABE -Type of ET, start date of ET -End date of first-line treatment, reason for termination (e.g., disease progression) 2 Data related to second-line treatment -Start date of second-line treatment -Type of second-line treatment (drug name) -End date of second-line treatment, reason for termination (e.g., disease progression) 3 Data related to chemotherapy -Start date of the first chemotherapy used for AMBC -First chemotherapy used for AMBC (drug name) 4 Data collected regardless of time point 1. Pathological findings -Histological type, Histological grade (or nuclear grade), ER/PgR expression status (IHC staining percentage or Allred score), HER2 expression status (IHC score or ISH determination) 2. Surgery/perioperative treatment -Surgery (surgery date), perioperative drug therapy (drugs used, start date, end date) -AMBC diagnosis date 3. Subsequent treatment -For the ET monotherapy group, whether CDK4/6 inhibitors were used in subsequent treatment -Drugs used (both ABE+ET and ET) 4. Outcome -Outcome (if died, whether it was due to the primary disease), date of outcome confirmation

Countries of Recruitment（Except Japan）	none