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JBCRG-M01
Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer, Phase I/II
- Status
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Study Closed
- Objectives
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To evaluate the safety and efficacy of a combination chemotherapy with CPT-11 and S-1 in recurrent or metastatic breast cancer patients with prior chemotherapy with anthracycline and taxane
- Subjects
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- Endpoints
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Primary endpoint: Phase I: MTD, DLT, RD, Phase II: Clinical response, Clinical efficacy, Secondary endpoints: Phase II: Adverse events, TTP, OS
- Trial Period
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July 2006 - July 2010
- Lead Principal Investigator
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Masakazu Toi (Department of Surgery, Breast Surgery, Graduate School of Kyoto University)
- Target Sample Size
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Phase I: 6 - 12, Phase II: 37, Total: 43 - 49
- Regimen
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CPT11+S1
- Source of Funding
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Advanced Clinical Research Organization (ACRO) (Cost for genetic polymorphism analysis)
- Conference Presentation
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Phase I/II pharmacokinetics/pharmacodynamics study of irinotecan and S-1 for recurrent/metastatic breast cancer in patients with select UGT1A1 genotypes (The JBCRG-M01 study)
- Articles and Publications
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A phase I/II pharmacokinetics/pharmacodynamics study of irinotecan combined with S-1 for recurrent/metastatic breast cancer in patients with selected UGT1A1 genotypes (the JBCRG-M01 study)
- UMIN-ID
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UMIN000000517
- jRCT
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- Memo
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- COI Disclosure
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