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JBCRG-17
Efficacy study of sequential therapy with anthracycline, taxane, and eribulin in patients with HER2-negative locally advanced breast cancer (JBCRG-17)
- Status
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Study Closed
- Objectives
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Evaluate the clinical response rate of sequential therapy with anthracycline, taxane, and eribulin in patients with HER2-negative locally advanced breast cancer. In addition, evaluate the histological effect, safety, and clinical efficacy. The clinical efficacy endpoints include the rate of radical surgery and breast-conserving surgery, survival period without metastasis, and overall survival period. In additional study, relationship between anticancer efficacy of eribulin and biological characteristics of cancer tissues are evaluated using molecular biological and biological methods.
- Subjects
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- Endpoints
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Primary endpoints: The clinical response rate of sequential therapy with anthracycline, taxane, and eribulin. Secondary endpoints: (1) The histological response rate of sequential therapy with anthracycline, taxane, and eribulin. (2) Clinical efficacy, rate of radical surgery, and rate of breast-conserving surgery. (3) Safety evaluation (occurrence of adverse events) (4) Exploration of clinicopathological and molecular biological markers related to prediction of cytoreductive effects. (5) Overall survival and recurrence-free survival (6) Clinical efficacy of eribulin after the treatment with anthracycline and taxane. Exploratory endpoints: Exploratory assessment of differences in response rate of eribulin with differences in sequence of administration of anthracycline and taxane.
- Trial Period
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Dec.2012 to May.2025 (2 and a half years)
- Lead Principal Investigator
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Yoshinori Ito(Cancer Institute Hospital, Japanese Foundation for Cancer Research )/ Norikazu Masuda(Osaka National Hospital)
- Target Sample Size
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60
- Regimen
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- Source of Funding
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JBCRG(Japan Breast Cancer research Group)
- Conference Presentation
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Efficacy study of sequential therapy with anthracycline, taxane, and eribulin in patients with HER2-negative locally advanced breast cancer (JBCRG-17).
- Articles and Publications
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A phase II study of sequential treatment with anthracycline and taxane followed by eribulin in patients with HER2-negative, locally advanced breast cancer (JBCRG-17)
- UMIN-ID
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UMIN000009639
- jRCT
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- Memo
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- COI Disclosure
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