HER2-positive Breast Cancer Clinical Trial
Official title:
Phase I Study of Adoptive T-Cell Therapy With HER-2/Neu (HER-2)-Specific Memory CD8+ T Lymphocytes Obtained Following In Vivo Priming With a Peptide Vaccine in Patients With Advanced Stage HER-2-Positive Breast Cancer
RATIONALE : Laboratory-treated T cells may stimulate the immune system in different ways and
stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Vaccines made from HER2 peptides may help the body build an effective
immune response to kill tumor cells that express HER2. Giving laboratory-treated T cells and
cyclophosphamide after vaccine therapy may be an effective treatment for breast cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of ex vivo-expanded
HER2-specific T cells when given together with cyclophosphamide after vaccine therapy in
treating patients with HER2-positive stage IV breast cancer.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of expanding HER-2-specific effector T cells (TE) ex vivo
from CD62L+ TCM and CD62L- TEM from patients immunized with a HER-2 peptide vaccine.
II. To evaluate the safety of infusing autologous ex vivo expanded HER-2-specific T cells
into patients with advanced HER-2+ breast cancer.
SECONDARY OBJECTIVES:
I. To evaluate the persistence, function, and phenotype of adoptively transferred
HER-2-specific TE cells derived from TCM or TEM precursors.
II. To investigate the potential anti-tumor effects of therapy with ex vivo expanded
HER-2-specific T cells in patients with advanced HER-2+ breast cancer.
OUTLINE : This is a dose-escalation study of ex vivo-expanded HER2-specific T cells.
VACCINE THERAPY: Patients receive HER2 peptide vaccine intradermally once weekly for 3
weeks.
CHEMOTHERAPY: Patients receive cyclophosphamide IV on day -1.
IMMUNOTHERAPY: Patients receive ex vivo-expanded HER2 specific T-cell IV over 30 minutes on
days 1, 10, and 20.
After completion of study treatment, patients are followed up on days 28, 35, 49, 63 and
then monthly thereafter for 1 year.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04095390 -
A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT04578106 -
Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
|
Phase 2 | |
| Completed |
NCT01855828 -
Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
|
Phase 2 | |
| Terminated |
NCT01912963 -
Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer
|
Phase 2 | |
| Terminated |
NCT01705340 -
Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery
|
Phase 1 | |
| Recruiting |
NCT04094896 -
TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT06087120 -
Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
|
||
| Recruiting |
NCT05346861 -
Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab
|
Phase 3 | |
| Recruiting |
NCT04899908 -
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
|
Phase 2 | |
| Completed |
NCT03330561 -
PRS-343 in HER2-Positive Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04997798 -
Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT04034823 -
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT04756921 -
18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response
|
||
| Completed |
NCT03140553 -
TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT03094052 -
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib
|
Phase 2 | |
| Recruiting |
NCT05511844 -
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05325632 -
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
|
Phase 2 | |
| Recruiting |
NCT06161922 -
Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
|
||
| Recruiting |
NCT05710666 -
Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study)
|
Phase 2 | |
| Not yet recruiting |
NCT05063643 -
Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude
|