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JBCRG-M07 (FUTURE)
Fulvestrant with additional palbociclib in advanced or metastatic HR-positive HER2-negative breast cancer after progression to fulvestrant monotherapy.
-FUTURE trial a multicenter study-
- Status
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No Longer Recruiting
- Objectives
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1)Collect Information of PFS and safety in Fulvestrant + Palbociclib for patients with resistant Fulvestrant
2)Collect Information of PFS in Fulvestrant as 1st and 2nd line therapy for HR-positive MBC
3)We assessed the biomarker and mechanism of drug resistance on Fulvestrant monotherapy and Fulvestrant + Palbociclib
- Subjects
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- Endpoints
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Primary: Progression-free survival: PFS,
Secondary: Overall Survival, Overall response rate, Time to treatment failure (TTF), Safety, Translational Research
- Trial Period
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Enrollment：Dec.2017－May 2019, Observation：to May 2020, Follou up： to May, 2021
- Lead Principal Investigator
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1)Naoki Niikura (Tokai University School of Medicine), 2)Shigehira Saji (Fukushima Medical University )
- Target Sample Size
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1st phase：200, 2nd phase：70
- Regimen
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Fulvestrant + Palbociclib
- Source of Funding
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AstraZeneca K.K.
- Conference Presentation
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Fulvestrant with additional palbociclib in advanced or metastatic hormone receptor-positive HER2-negative breast cancer after progression to fulvestrant monotherapy: JBCRG- M07 (FUTURE trial)
Fulvestrant with additional palbociclib in advanced or metastatic hormone receptor-positive HER2–negative breast cancer after progression to fulvestrant monotherapy: JBCRG- M07 (FUTURE trial)
- Articles and Publications
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- UMIN-ID
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UMIN000029294
- jRCT
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jRCTs021180028
- Memo
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- COI Disclosure
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COI Disclosure_M07_20220613
