Clinical Trial: NCT05325632
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
Status:
RECRUITINGPhase:
Phase 2| Lead Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
| Information Provided By: | H. Lee Moffitt Cancer Center and Research Institute |
| Last Update Posted: | 2026-03-02 |
Study Overview
Brief Summary
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.
Official Title
A Phase II Study of Human Epidermal Growth Factor Receptor 2 (HER-2) Directed Dendritic Cell (DC1) Vaccine Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer
Conditions
HER2-positive Breast Cancer
Intervention / Treatment
- Biological: HER-2 pulsed DC1
- Drug: Trastuzumab
- Drug: Pertuzumab
- Drug: Paclitaxel
- Procedure: Resection surgery
Other Study ID Numbers
- MCC-20915
Start Date (Actual)
2021-10-28
Primary Completion Date (Estimated)
2027-02
Study Completion Date (Estimated)
2027-09
Enrollment (Estimated)
53
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
| Information Provided By: | H. Lee Moffitt Cancer Center and Research Institute |
| Last Update Posted: | 2026-03-02 |
Study Overview
Brief Summary
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.
Official Title
A Phase II Study of Human Epidermal Growth Factor Receptor 2 (HER-2) Directed Dendritic Cell (DC1) Vaccine Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer
Conditions
HER2-positive Breast Cancer
Intervention / Treatment
- Biological: HER-2 pulsed DC1
- Drug: Trastuzumab
- Drug: Pertuzumab
- Drug: Paclitaxel
- Procedure: Resection surgery
Other Study ID Numbers
- MCC-20915
Start Date (Actual)
2021-10-28
Primary Completion Date (Estimated)
2027-02
Study Completion Date (Estimated)
2027-09
Enrollment (Estimated)
53
Study Type
Interventional
Phase
Phase 2