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JBCRG-C10
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
- Status
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No Longer Recruiting
- Objectives
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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.
- Subjects
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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
- Endpoints
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Chemotherapy-free survival (CFS)
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
- Trial Period
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October 1, 2023 - December 31, 2024
- Lead Principal Investigator
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Osaka University Hospital
Tetsuhiro Yoshinami
- Target Sample Size
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400
- Regimen
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- 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
- 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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UMIN000051975
- jRCT
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- Memo
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- COI Disclosure
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