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JBCRG-19
Study on the clinical efficacy of Eribulin as the first- or second-line treatment in patients with recurrent HER2- negative breast cancer (randomized Phase II study)(JBCRG-19)
- Status
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Study Closed
- Objectives
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Progression-free survival (PFS) with Eribulin as the first- or second-line line therapy is examined in patients with recurrent HER2- negative breast cancer, and the clinical efficacy of Eribulin is shown by comparing it with treatment of the physician's choice (TPC).
- Subjects
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- Endpoints
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1) Female patients with a histological diagnosis of invasive breast cancer. 2) Recurrent HER2-negative breast cancer 3) ECOG performance status(PS)0 - 1. 4) Patients with measurable lesions by RECIST. 5) Patients with a history of neoadjuvant or adjuvant therapy with anthracyclines and taxanes. Patients at least 6 months after neoadjuvant or adjuvant therapy in case of taxanes. 6) Patients in whom Eribulin has not been used in the pretreatment. 7）Patients with no or one prior metastatic breast cancer chemotherapy regimens. 8) Patients in whom the major organ functions have been maintained. The criteria listed below are all met within 14 days before enrollment. (1) Neutrophil count: At least 1,500/mm3 (2) Platelet count: At least 100,000 mm3 (3) Hemoglobin: At least 9.0 g/dL (4) Total bilirubin: Not exceeding 2.0 mg/dL (5) AST (GOT) and ALT (GPT): Under 100 IU/L(Under 150 IU/L for patients who has hepatic metastasis) (6) Serum creatinine: Not exceeding 1.5 mg/dL 9) Patients with no clinical problems on electrocardiography. 10) Patients from whom written consent for participation in the study has been obtained in person.
- Trial Period
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Feb2013 to Jan 2017 (3 year entry)
- Lead Principal Investigator
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Kenjiro Aogi (Shikoku Cancer Center, Department of Breast and Endocrine Surgery)
- Target Sample Size
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80
- Regimen
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- Source of Funding
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JBCRG (Japan Breast Cancer Research Group)
- Conference Presentation
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Clinical efficacy of eribulin as a first- or second-line treatment for patients with recurrent HER2-negative breast cancer : a phase II randomized study (JBCRG-19)
- Articles and Publications
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Clinical usefulness of eribulin as first- or second-line chemotherapy for recurrent HER2-negative breast cancer: a randomized phase II study (JBCRG-19)
- UMIN-ID
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UMIN000009886
- jRCT
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- Memo
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- COI Disclosure
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