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JBCRG-M05 (PRECIOUS)
A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Locally Advanced and Metastatic Breast Cancer（Study of Perjeta re-treatment for clinical outcomes）
- Status
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No Longer Recruiting
- Objectives
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To evaluate the efficacy and safety of pertuzumab, trastuzumab and chemotherapy as a pertuzumab retreatment compared to trastuzumab and chemotherapy in locally advanced or metastatic breast cancer patients for previously treated with pertuzumab
- Subjects
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- Endpoints
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Primary outcomes:Progression-free survival (assessed by investigators) Secondary outcomes:PFS (assessed by independent review), PFS in patients treated with trastuzumab emtansine (T-DM1) as the latest regimen, Response rate, Duration of response, Overall survival (OS), Patient-reported-outcome (QOL), Safety, biomarkers
- Trial Period
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Aug 2015 to Jul 2019
- Lead Principal Investigator
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1)Hiroji Iwata (Aichi Cancer Center Hospital, Department of Breast Oncology) 2)Yutaka Yamamoto(Kumamoto University Hospital, Department of Breast and Endocrine Surgery)
- Target Sample Size
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370
- Regimen
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Trastuzumab + chemotherapy, Trastuzumab+ pertuzuma
- Source of Funding
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Japan Breast Cancer Research Group (JBCRG) Chugai Pharmaceutical Co., Ltd.
- Conference Presentation
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PRECIOUS: Pertuzumab re-treatment for HER2-positive locally advanced/metastatic breast cancer (JBCRG-M05)
A randomized, open-label, phase III trial of pertuzumab re-treatment in HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab, trastuzumab, and chemotherapy: The Japan Breast Cancer Research Group-M05 (PRECIOUS) study
PRECIOUS: A randomized, open-label phase III trial of pertuzumab retreatment in HER2-positive locally advanced/metastatic breast cancer patients who were previously treated with pertuzumab, trastuzumab, and chemotherapy (JBCRG-M05).
- Articles and Publications
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Pertuzumab retreatment for HER2-positive advanced breast cancer: a randomized, open-label phase III study
- UMIN-ID
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UMIN000018202
- jRCT
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jRCTs041180153
- Memo
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- COI Disclosure
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COI Disclosure_M05_20220906
