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Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

StatusRecruiting
PhasePhase 3
Started2023-12-30
View on ClinicalTrials.gov ↗

Amendment history

2026-06-11
minor
Study Status, Contacts/Locations v19
Study sites86→88
2026-04-07
minor
Study Status, Contacts/Locations v18
Study sitesdetails revised at 5 of 86 sites
2026-02-05
minor
Study Status, Contacts/Locations v17
Study sites84→86
2025-10-31
minor
2 amendments v15-v16
2 re-verifications since 2025-09-08, no change to tracked fields
2025-07-28
minor
Study Status, Contacts/Locations v14
Study sites83→84
Show 13 earlier versions
2025-06-30
minor
Study Status v13
Re-verified, no change to tracked fields
2025-04-28
minor
Study Status, Contacts/Locations v12
Study sites70→83
2025-03-24
minor
Study Status, Contacts/Locations v11
Study sites61→70
2025-01-29
minor
Study Status, Contacts/Locations v10
Study sites54→61
2024-12-23
minor
Study Status, Contacts/Locations v9
Study sites46→54
2024-12-02
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Study Status, Contacts/Locations v8
Study sites39→46
2024-10-28
minor
Study Status, Contacts/Locations v7
Study sites24→39
2024-09-24
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Study Status, Contacts/Locations v6
Study sites18→24
2024-09-03
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Study Status, Contacts/Locations v5
Study sites14→18
2024-07-03
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Study Status, Contacts/Locations v4
Study sites12→14
2024-07-02
minor
Study Status, Contacts/Locations v3
Study sites1→12
2024-01-02
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-12-31→confirmed 2023-12-30
Study sites0→1
2023-11-29
minor
Study Status v1
Primary completion date2027-10→2027-10-01
Completion date2027-10→2027-10-01
Start date2023-10→2023-12-31
2023-07-10
minor
Original filing
69 trials monitored
See 8 trials at risk
5,180 trials monitored
See 256 trials at risk
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.
Trial Details
NCT Number NCT05950945
Lead Sponsor Daiichi Sankyo
Collaborators: AstraZeneca
Conditions Breast Cancer
Enrollment 250 participants
Start Date 2023-12-30
Primary Completion 2027-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-12