Jan. 22, 2023 |
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Jan. 19, 2024 |
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jRCT2061220087 |
A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03) |
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A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03) |
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 |
Feb. 28, 2023 |
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Mar. 24, 2023 | ||
1075 | ||
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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Participant must be >= 18 years at the time of screening. |
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Stage IV (metastatic) TNBC. |
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18age old over | ||
130age old under | ||
Both |
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Breast Cancer |
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Arm 1: Dato-DXd 6 mg/kg IV Q3W x 8 cycles + Durvalumab 1120 mg IV Q3W x 9 cycles |
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Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT [ Time Frame: From randomization until recurrence as assessed by investigator or death due to any cause up to 57 months from first subject in ] |
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Distant disease-free survival (DDFS) for Dato-DXd + durvalumab vs ICT |
DAIICHI SANKYO Co.,Ltd. |
AstraZeneca | |
Applicable |
IRB of Okayama University Hospital | |
2-5-1 Shikata-cho, Kita-ku,Okayama-city, Okayama | |
+81-86-223-7151 |
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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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. 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 |
NCT05629585 | |
ClinicalTrials.gov |
Belgium/Brazil/Canada/China/Germany/Korea/Spain/Taiwan/United Kingdom/United States |