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JBCRG-M06 (EMERALD)
A phase III clinical study to compare the combination therapy of eribulin mesylate + pertuzumab + trastuzumab with paclitaxel or docetaxel + pertuzumab + trastuzumab
- Status
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No Longer Recruiting
- Objectives
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To verify that combination therapy with trastuzumab + pertuzumab + eribulin brings similar PFS and better QOL compared to trastuzumab + pertuzumab + taxane in advanced/recurrent HER2-positive breast cancer patients who have no medical history of chemotherapy except ado-trastuzumab emtansine
- Subjects
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- Endpoints
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Primary outcomes: Progression-free survival: PFS Secondary outcomes 1.Response rate 2.Duration of response 3.Overall survival 4. Patient-reported outcomes 5.Safety 6.Biomaker 7.new Metastases free survival 8. Treatment duration of next treatment
- Trial Period
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Aug.,2017 to Oct.,2023
- Lead Principal Investigator
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Toshinari Yamashita, Kanagawa Cancer Center Norikazu Masuda, National Hospital Organization Osaka Medical Center Shigehira Saji, Fukushima Medical University
- Target Sample Size
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480
- Regimen
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HER+PER+Eri vs HER+PER+Taxane
- Source of Funding
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Eisai Co., Ltd. Japan Breast Cancer Research Group
- Conference Presentation
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- Articles and Publications
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Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive locally advanced or metastatic breast cancer: study protocol for a randomized controlled non-inferiority (phase III) trial in Japan (JBCRG-M06/EMERALD)
- UMIN-ID
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UMIN000027938
- jRCT
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jRCTs021180027
- Memo
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- COI Disclosure
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COI Disclosure_M06_20240612
