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A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

StatusActive, Not Recruiting
PhasePhase 3
Started2020-12-04
View on ClinicalTrials.gov ↗

Amendment history

2026-06-30
Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v38
Enrollment targetestimated 1600→confirmed 1635
Secondary endpoints7 entries, revised
Disease-free Survival (DFS) in Participants Who Were AdministeredRandomized to Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Em [...] 1) Treatment Overall Survival (OS) in Participants Who Were AdministeredRandomized to Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Em [...] nt Recurrence-free Interval (DRFI) in Participants Who Were AdministeredRandomized to Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Em [...] in Metastases-free Interval (BMFI) in Participants Who Were AdministeredRandomized to Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Em [...] Treatment-emergent Adverse [...]
Primary endpoints1 entry, revised
Invasive Disease-free Survival (IDFS) in Participants Who Were AdministeredRandomized to Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment
2026-05-14
Study Status, Study Design, Contacts/Locations v37
Enrollment target1635→1600
Study sites481→482
2026-05-08
Study Status, Study Design v36
Primary completion dateestimated 2025-12-31→confirmed 2025-07-02
Completion date2030-12-31→2028-06-20
Enrollment targetestimated 1600→confirmed 1635
2025-05-07
Study Status, Contacts/Locations v35
Study sites482→481
2024-10-07
2 amendments v33-v34
2 re-verifications since 2024-06-26, no change to tracked fields
Show 32 earlier versions
2023-12-18
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v32
Trial statusRecruiting→Active, Not Recruiting
Study sites506→482
2023-11-03
Study Status, Contacts/Locations v31
Study sites506 entries, revised
Istitutoperla Ricercaela Curadel Cancro IRCC Istituto Nazdi perCandiolo la- RicercaIRCCS Ospedale sulPoli CancroSAN (IST) GenovMARTINO
2023-08-31
Study Status, Contacts/Locations v30
Study sitesdetails revised at 1 of 506 sites
2023-08-01
Study Status, Contacts/Locations v29
Study sitesdetails revised at 1 of 506 sites
2023-06-30
Study Status, Contacts/Locations v28
Study sitesdetails revised at 4 of 506 sites
2023-05-26
Study Status, Contacts/Locations v27
Study sitesdetails revised at 11 of 506 sites
2023-04-11
Study Status, Outcome Measures, Eligibility, IPDSharing v26
Completion date2027-09-01→2030-12-31
Eligibility criteria+249 characters
[...] gal age of consent for study participation is >18 years old). Pathologically documented HER2-positive breast cancer (BC): [...] u hybridization (ISH) confirmed prior to study randomization. Histologically confirmed invasive breast carcinoma. Clinical stage at disease presentation: T1-4, N0-3, M0; patients presenting with T1N0 tumors are not eligible. Pathologic evidence of residual invasive carcinoma in the b [...] ), defined as clinical stages T4, N0-3, M0 or T1-3, N2-3, M0. Operable at presentation, defined as clinical stages T1-3,N [...] node positive disease (ypN1-3) following neoadjuvant therapy. Completion o [...] [...]
2023-02-02
Study Status, Contacts/Locations v25
Study sites502→506
2022-11-07
Study Status, Contacts/Locations v24
Study sites501→502
2022-09-21
Study Status, Contacts/Locations v23
Study sitesdetails revised at 6 of 501 sites
2022-08-17
Study Status, Contacts/Locations v22
Study sitesdetails revised at 1 of 501 sites
2022-08-02
Study Status, Contacts/Locations v21
Study sites499→501
2022-07-07
Study Status, Contacts/Locations v20
Study sites498→499
2022-06-13
Study Status, Contacts/Locations, IPDSharing v19
Study sites497→498
2022-05-03
Study Status, Contacts/Locations v18
Study sitesdetails revised at 7 of 497 sites
2022-04-11
Study Status, Contacts/Locations v17
Study sites496→497
2022-03-15
Study Status, Contacts/Locations v16
Study sites467→496
2022-02-28
Study Status, Contacts/Locations v15
Study sites457→467
2022-01-06
Study Status, Contacts/Locations v14
Study sitesdetails revised at 18 of 457 sites
2021-12-21
Study Status, Contacts/Locations v13
Study sitesdetails revised at 1 of 457 sites
2021-12-09
Study Status, Contacts/Locations v12
Study sites433→457
2021-11-04
Study Status, Contacts/Locations v11
Study sites432→433
2021-10-06
Study Status, Contacts/Locations v10
Study sites428→432
2021-09-01
Study Status, Contacts/Locations v9
Study sitesdetails revised at 22 of 428 sites
2021-08-06
Study Status, Contacts/Locations v8
Study sitesdetails revised at 20 of 428 sites
2021-07-08
Study Status, Contacts/Locations v7
Study sites425→428
2021-06-01
Study Status, Contacts/Locations v6
Study sites424→425
2021-05-04
Study Status, Contacts/Locations v5
Study sites423→424
2021-04-08
Study Status, Contacts/Locations v4
Study sitesdetails revised at 13 of 423 sites
2021-03-01
Study Status, Contacts/Locations v3
Study sitesdetails revised at 5 of 423 sites
2021-02-03
Study Status, Contacts/Locations v2
Study sitesdetails revised at 9 of 423 sites
2021-01-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-11-30→confirmed 2020-12-04
Study sitesdetails revised at 423 of 423 sites
2020-11-06
Original filing
Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.
Trial Details
NCT Number NCT04622319
Lead Sponsor Daiichi Sankyo
Collaborators: AstraZeneca, NSABP Foundation Inc, GBG Forschungs GmbH, Spanish Breast Cancer Research Group (SOLTI)
Conditions HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer
Enrollment 1,600 participants
Start Date 2020-12-04
Primary Completion 2025-07-02 (estimated)
Study Completion 2028-06-20 (estimated)
Updated on ClinicalTrials.gov 2026-05-15