Nov. 02, 2021 |
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Dec. 13, 2023 |
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jRCT2041210097 |
A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11) |
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A Phase 3 Trial of Neoadjuvant T-DXd Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11) |
Inoguchi Akihiro |
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DAIICHI SANKYO Co.,Ltd. |
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1-2-58, Hiromachi, Shinagawa-ku, Tokyo |
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+81-3-6225-1111 |
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dsclinicaltrial@daiichisankyo.co.jp |
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Contact for Clinical Trial Information |
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DAIICHI SANKYO Co.,Ltd. |
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1-2-58, Hiromachi, Shinagawa-ku, Tokyo |
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+81-3-6225-1111 |
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dsclinicaltrial@daiichisankyo.co.jp |
Recruiting |
Nov. 15, 2021 |
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Nov. 16, 2021 | ||
900 | ||
Interventional |
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randomized controlled trial |
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open(masking not used) |
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active control |
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parallel assignment |
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treatment purpose |
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Key Inclusion Criteria: |
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Exclusion Criteria: |
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18age old over | ||
No limit | ||
Both |
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HER2-positive early breast cancer |
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- Arm A: T-DXd (5.4 mg/kg Q3W) x 8 cycles. |
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rate of pathologic complete response (pCR) [ Time Frame: Following completion of neoadjuvant therapy ] |
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- rate of pathologic complete response (pCR) [ Time Frame: Following completion of neoadjuvant therapy ] |
Daiichi Sankyo Co., Ltd. |
AstraZeneca | |
Applicable |
Nagoya City University Institutional Review Board | |
1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8602, Aichi | |
+81-52-851-5511 |
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clinical_research@med.nagoya-cu.ac.jp | |
Approval | |
Yes |
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Plan Description: Qualified researchers can request access to anonymized individual patient data from AstraZeneca Group of Companies, sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ Disclosure Commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Supporting Materials: Study Protocol Statistical Analysis Plan (SAP) Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Access Criteria: When a request has been approved, AstraZeneca will provide access to the de-identified patient level data in an approved sponsor tool. Signed Data Sharing Agreements (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure |
Italy/India/Canada/South Korea/Saudi Arabia/Spain/Philppines/Thailand/Taiwan/China/Germany/Austria/Bulgaria/USA/Poland/Brazil/Peru/Russia |