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JBCRG-S04
NEW
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
- Status
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Now Recruiting
- Objectives
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To clarify the treatment practices of abemaciclib (ABE) plus endocrine therapy (ET) and ET alone as first-line treatments for hormone receptor-positive, HER2-negative advanced metastatic breast cancer (AMBC) in Japan
- Subjects
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Eligible subjects enrolled in JBCRG-C10 (C10 Cohort) or ABCD Project (ABCD Cohort)
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.
- Endpoints
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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
- Trial Period
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Contract signing date ～ Dec. 31. 2026
- Lead Principal Investigator
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Tetsuhiro Yoshinam (Department of Breast and Endocrine Surgery, Graduate School of Medicine, Osaka University)
Yasuaki Sagara (Department of Breast and Thyroid Surgical Oncology, Hakuaikai Sagara Hospital)
- Target Sample Size
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C10 Cohort:
・ABE+ET combination group: Approximately 250 subjects
ABCD Cohort:
・ET alone group: All subjects that started treatment from 2019 onwards (When compared with the C10 cohort, all cases that started treatment between January 1, 2019, and December 31, 2021)
・ABE+ET combination group: All subjects that started treatment from 2019 onwards
- Regimen
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Observational study using real world data (RWD) to clarify the treatment practices of first-line treatment for AMBC in Japan
- Source of Funding
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Eli Lilly Japan K.K
- Conference Presentation
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- Articles and Publications
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- UMIN-ID
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- jRCT
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jRCT1070250028
- Memo
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- COI Disclosure
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