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Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas

StatusRecruiting
PhasePhase 2
Started2020-12-24
View on ClinicalTrials.gov ↗

Amendment history

2026-04-07
Study Status, Study Design, Arms and Interventions, Contacts/Locations v8
Enrollment reduced: 55 → 37 participants
Study sites12→13
2026-02-23
Study Status v7
Primary completion date2026-02-01→2028-02-01
Completion date2027-02-01→2029-02-01
2025-02-17
Study Status v6
Primary completion date2025-02-01→2026-02-01
Completion date2026-02-01→2027-02-01
2024-04-02
Study Status, Contacts/Locations v5
Study sites3→12
2023-04-12
Study Status, Contacts/Locations v4
Study sites2→3
Show 3 earlier versions
2023-01-02
2 amendments v2-v3
2 re-verifications since 2021-12-27, no change to tracked fields
2020-12-24
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-03→confirmed 2020-12-24
Study sitesdetails revised at 2 of 2 sites
2020-11-05
Original filing
This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.
Trial Details
NCT Number NCT04620187
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Genentech, Inc.
Conditions Salivary Gland Cancer, HER2 Gene Mutation
Enrollment 37 participants
Start Date 2020-12-24
Primary Completion 2028-02-01 (estimated)
Study Completion 2029-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-13