June. 04, 2021 |
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Sept. 07, 2023 |
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jRCT2031210130 |
Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09) |
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Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer |
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 |
Not Recruiting |
July. 01, 2021 |
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Aug. 23, 2021 | ||
1134 | ||
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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- Patients must be >=18 years of age(>=20 years of age - applicable for Japan only) |
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- Ineligible for any of the agents on the study. |
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18age old over | ||
130age old under | ||
Both |
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Breast Cancer; HER2-positive; Metastatic |
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Experimental: Arm A |
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Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment |
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1.Progression Free Survival (PFS) by Investigator assessment |
Daiichi Sankyo Co., Ltd. |
AstraZeneca | |
Applicable |
Center Hospital of the National Center for Global Health and Medicine IRB | |
Toyama 1-21-1, Shinjuku-ku, Tokyo | |
+81-3-3202-7181 |
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Approval | |
Yes |
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Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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 rerefer 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 individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (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. URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home |
NCT04784715 | |
ClinicalTrials.gov |
Argentina/ Canada/ China/Denmark/Hungary/ India/ Italy/Korea/Peru/Philippines/Russian Federation/Saudi Arabia/Saudi Arabia/ Spain/Sweden/Taiwan/Turkey/United Kingdom/United States |