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JBCRG-C11（CREA）
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A multicenter prospective observational study in patients with HER2-positive advanced or metastatic breast cancer who achieved a Complete REsponse to trAstuzumab deruxtecan (CREA)
- Status
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Now Recruiting
- Objectives
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To explore the status and treatment after complete response (CR) with trastuzumab deruxtecan (T-DXd). In addition, the optimal treatment after CR will be explored using biomarkers.
- Subjects
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1. Patients who have diagnosed with HER2 positive inoperable or recurrent breast cancer
2. Patients who are at least 18 years of age at the time of obtaining consent
3. Patients who have been judged by their physicians to achieve complete response on imaging after receiving T-DXd
4. Patients who have given written consent to participate in this study
- Endpoints
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1. Duration of complete response (DoCR)
2. Progression-free survival (PFS)
3. Overall survival (OS)
4. Time to treatment failure (TTF)
5. Time to next treatment (TTNT)
6. TTF2
7. TTNT2
8. Adverse events
9. Biomarkers (presence/absence of ctDNA detection)
- Trial Period
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Research permission date - December 31, 2028
- Lead Principal Investigator
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National Cancer Center Hospital East
Yoichi Naito
- Target Sample Size
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100
- Regimen
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Trastuzumab deruxtecan (T-DXd)
- Source of Funding
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DAIICHI SANKYO COMPANY, LIMITED
- Conference Presentation
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- Articles and Publications
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- UMIN-ID
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- jRCT
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jRCT1031240010
- Memo
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- COI Disclosure
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