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JBCRG-M08 (AMBER)
NEW
Innovation of the 1st line strategy optimized as abemaciclib with endocrine therapy based on the ESR1 mutation of ctDNA for HR-positive HER2-negative advanced metastatic breast cancer patients - Multi-institutional phase 2 trial
- Status
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Now Recruiting
- Objectives
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To explore the efficacy of a treatment strategy to select an endocrine agent based on assessment of ESR1 mutation status by ctDNA analysis in patients who continue abemaciclib and aromatase inhibitor combination therapy for at least 6 months as first-line treatment for hormone receptor (HR)-positive, HER2-negative advanced metastatic breast cancer.
- Subjects
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Hormone receptor-positive, HER2-negative inoperable or recurrent breast cancer
- Endpoints
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2-year PFS rate from the secondary enrollment (all arms)
- Trial Period
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- Lead Principal Investigator
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Tetsuhiro Yoshinami, MD, PhD.
Department of Breast and Endocrine Surgery, Osaka University Hospital
- Target Sample Size
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Secondary enrollment: 150 patients
- Regimen
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Repeated "ctDNA measurements" will be performed for the eligible patients treated with Aromatase inhibitor + abemaciclib combination therapy (AI + ABE) as first-line treatment.
In case of ESR1 mutation detected by "ctDNA measurement", treatment would change.
Protocol treatment overview
1) AI + ABE continued for 3 months after primary registration
2) If no sign of PD is seen on the images after 3 months from the primary registration, secondary registration will be performed.
3) After secondary registration, treatment will be decided based on ESR1 mutation status of ctDNA measurement.
・ ctDNA evaluation period: before secondary registration, 24 weeks, 48 weeks after secondary registration
・In case of ESR1 mutation detected at any point, AI + ABE change to fulvestrant (FUL) + ABE.
・ In case of no ESR1 mutation detected at either point, AI + ABE will be continued.
4) ctDNA measurement will be performed at 24 weeks after start of FUL + ABE.
・In case of ESR1 mutation detected at this point, FUL + ABE will be continued
・In case of no ESR1 mutation detected at this point, FUL will be stopped and AI + ABE will be resumed.
- 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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jRCTs051220133
- Memo
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- COI Disclosure
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COI Disclosure_M08_20240307
