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Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab

StatusRecruiting
PhasePhase 2
Started2021-10-28
View on ClinicalTrials.gov ↗

Amendment history

2026-02-26
Study Status v14
Primary completion date2026-09→2027-02
Completion date2026-09→2027-09
2025-12-08
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 1 site
2025-09-18
Study Status v12
Primary completion date2025-10→2026-09
Completion date2026-10→2026-09
2025-05-21
Study Status v11
Re-verified, no change to tracked fields
2025-02-28
Study Status v10
Primary completion date2025-01-31→2025-10
Completion date2025-01-31→2026-10
Show 9 earlier versions
2024-12-20
Study Status v9
Re-verified, no change to tracked fields
2024-08-06
Study Status, Outcome Measures v8
Secondary endpointsdetails revised at 1 of 4 entries
2024-07-09
Study Status v7
Re-verified, no change to tracked fields
2024-02-08
Study Status, Contacts/Locations v6
Primary completion date2024-10-27→2025-01-31
Completion date2025-10→2025-01-31
2023-10-17
Study Status, Contacts/Locations v5
Study sitescontacts updated at 1 of 1 site
2023-08-03
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2023-04-21
Study Status, Study Design, Arms and Interventions v3
Enrollment target34→53
Study arms3→4
2023-03-28
Study Status v2
Start date2021-11-01→2021-10-28
2022-10-06
Study Status v1
Re-verified, no change to tracked fields
2022-04-08
Original filing
The purpose of the study is to find out if an investigational drug called Dendritic Cell (DC1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with HER2 (human epidermal growth factor receptor 2) positive breast cancer.
Trial Details
NCT Number NCT05325632
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: ImmunoRestoration
Conditions HER2-positive Breast Cancer
Enrollment 53 participants
Start Date 2021-10-28
Primary Completion 2027-02 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-02