DCIS Clinical Trial
Official title:
A Phase IB Trial of Neoadjuvant Multi-epitope HER2 Peptide Vaccine in Patients With HER2-expressing DCIS
This interventional clinical study will examine the safety and efficacy of a degenerate subdominant HER2 specific helper T cell epitope vaccine (H2NVAC) in patients with HER2-expressing ductal carcinoma in situ (DCIS). The ultimate goal of this vaccine is to prevent future invasive breast cancer among patients who are diagnosed with DCIS. However, the focus of this study is safety and efficacy.
This is an interventional clinical study examining the safety and efficacy of a degenerate subdominant HER2 specific helper T cell epitope vaccine (H2NVAC) in patients with HER2-expressing ductal carcinoma in situ (DCIS). The ultimate goal of this vaccine is to prevent future invasive breast cancer among patients who are diagnosed with DCIS. However, the focus of this study is safety and efficacy. The vaccine consists of 4 peptide epitopes (15-18 amino acids in length) derived from the HER2 protein. These peptides are derived from HER2 and were selected based upon their recognition by lymphocytes from women with prior HER-2 positive breast cancer. To enhance immunity, the peptides are admixed with the adjuvant GM-CSF. Patients will receive four bi-monthly vaccinations followed by surgery as diagrammed below; observation includes periodic blood draws to assess toxicity and immune responses, as well as periodic echocardiography to assess left ventricular ejection fraction. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00256217 -
Chemoprevention Trial - Anastrozole in Ductal Carcinoma In Situ (DCIS) in Postmenopausal Women
|
Phase 2 | |
| Completed |
NCT03931928 -
Genotype and Phenotype Guided Supplementation of TAMoxifen Standard Therapy With ENDOXifen in Breast Cancer Patients
|
Phase 2 | |
| Terminated |
NCT03535506 -
Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery
|
Phase 2 | |
| Recruiting |
NCT04797299 -
Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
|
||
| Completed |
NCT02637024 -
Trial of Radiation Fractionation Schedules for Once-a-Day Accelerated Partial Breast Irradiation
|
Phase 2 | |
| Completed |
NCT00148655 -
Educational Interventions for Patients With DCIS
|
N/A | |
| Suspended |
NCT03936478 -
Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT03878342 -
Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast
|
N/A | |
| Active, not recruiting |
NCT04245150 -
Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity
|
||
| Recruiting |
NCT06388304 -
THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence
|
N/A | |
| Not yet recruiting |
NCT06217458 -
The Added Value of Contrast Enhanced Mammography to Standard Mammography in Assessing the Extent of DCIS
|
N/A | |
| Recruiting |
NCT04722692 -
Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
|
Phase 3 | |
| Enrolling by invitation |
NCT05868252 -
Molecular Analysis of the Sloane Project
|
||
| Recruiting |
NCT05912569 -
Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS
|
N/A | |
| Recruiting |
NCT04049214 -
Perioperative Mindfulness Proposal
|
N/A | |
| Completed |
NCT02061332 -
DC Vaccine for Patients With Ductal Carcinoma In Situ
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04916808 -
The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing
|
||
| Withdrawn |
NCT05436808 -
Partial Chest Wall Radiation Therapy After Surgery for Lymph Node Negative Breast Cancer
|
Early Phase 1 | |
| Recruiting |
NCT05900986 -
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
|
Phase 1/Phase 2 | |
| Suspended |
NCT03448926 -
The PREDICT Registry for DCIS Patients With DCISionRT Testing
|