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JBCRG-18Gem
Phase I Clinical Study of Combination Therapy with Eribulin and Gemcitabine in Patients with Progressive Recurring Breast Cancer (JBCRG-18Gem)
- Status
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Study Closed
- Objectives
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In this clinical study, the maximum tolerated dose (MTD) will be estimated, based on the dose limiting toxicity of the combination therapy of eribulin (HAL) and gemcitabine (GEM) in patients with progressive recurring breast cancer, and the recommended dose (RD) for Phase II clinical study will be determined.
- Subjects
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- Endpoints
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Primary endpoints: MTD, DLT, RD Secondary endpoints: AE, ORR, PK
- Trial Period
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Dec.2012 to Nov.2014
- Lead Principal Investigator
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Hiroji Iwata(Dept. of Breast Oncology, Aichi Cancer Center Hospital )
- Target Sample Size
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9-24
- Regimen
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Combined therapy of Eribulin and Gemcitabine
- Source of Funding
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JBCRG (Japan Breast Cancer Research Group)
- Conference Presentation
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Phase Ib dose-escalation study of Eribulin (Eri) in combination with Gemcitabine (GEM) in patients (pts) with metastatic breast cancer (MBC) (JBCRG-18Gem)
- Articles and Publications
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- UMIN-ID
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UMIN000009612
- jRCT
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- Memo
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- COI Disclosure
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