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JBCRG-M04 (BOOSTER)
Bevacizumab plus paclitaxel optimization study with interventional maintenance endocrine therapy in advanced or metastatic ER-positive HER2-negative breast cancer -BOOSTER trial, a multicenter randomized phase II study-
- Status
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Study Closed
- Objectives
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To compare continuing bevacizumab + paclitaxel or switching to bevacizumab + endocrine maintenance therapy followed by bevacizumab + paclitaxel, after 1st line induction therapy with bevacizumab + paclitaxel in ER+HER2- advanced or metastatic breast cancer.
- Subjects
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- Endpoints
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Primary outcome: Time to failure of strategy (TFS)
Key secondary outcomes: 2y Overall Survival rate, Progression Free Survival(PFS), QOL, Biomarker, Safety
- Trial Period
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Jan 2014 to Dec 2015
- Lead Principal Investigator
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1)Shigehira Saji
2)Masakazu Toi
1) Department of Medical Oncology, Fukushima Medical University
2) Department of Breast Surgery , Kyoto University Graduate School of Medicine
- Target Sample Size
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160
- Regimen
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1)weekly paclitaxel + bevacizumab
2) endocrine therapy + bevacizumab then back to weekly paclitaxel + bevacizumab therapy
- Source of Funding
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Chugai Pharmaceutical Co., Ltd.
- Conference Presentation
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A randomized, multicenter, phase II study evaluating the efficacy of interventional maintenance endocrine therapy with Bevacizumab following fixed cycles of Bevacizumab plus Paclitaxel in advanced/metastatic ER-positive HER2-negative breast cancer: JBCRG-M04 BOOSTER trial
Patient-reported outcomes of a switch to maintenance endocrine therapy following induction chemotherapy versus continuation of chemotherapy in ER-positive HER2-negative metastatic breast cancer: a randomized, open-label, phase 2 clinical trial
A randomized, multicenter, phase II study evaluating the efficacy of interventional maintenance endocrine therapy with Bevacizumab following fixed cycles of Bevacizumab plus Paclitaxel in advanced/metastatic ER-positive HER2-negative breast cancer: JBCRG-M04 BOOSTER trial
Bevacizumab plus Paclitaxel optimization study with interventional maintenance endocrine therapyin advanced or metastatic ER-positive HER2-negative breast cancer: JBCRG-M04 (BOOSTER) trial, ASCO 2014
- Articles and Publications
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Switch maintenance endocrine therapy plus bevacizumab after bevacizumab plus paclitaxel in advanced or metastatic oestrogen receptor-positive, HER2-negative breast cancer (BOOSTER): a randomised, open-label, phase 2 trial.
- UMIN-ID
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UMIN000012179
- jRCT
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jRCTs021180026
- Memo
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- COI Disclosure
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COI Disclosure_M04_20200526
