Phase 1
N=15
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02063724 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Rate of Treatment Regimen Completion — 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- HER-2 pulsed Dendritic Cell Vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Treatment Regimen Completion |
14 | — |
| SECONDARY Immune Response |
15 | — |
| SECONDARY Occurrence of Treatment Related Adverse Events |
1; 2; 1; 1; 1; 2 | — |
Summary
The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram, laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine administration.
Eligibility Criteria
Inclusion Criteria
- Women over Age 18 years.
- Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than or equal to N2 (>4 positive nodes) or have recurrent metastatic breast cancer rendered NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+ FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1 year from their last treatment and have no evidence of disease.
- Deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations.
- Women of childbearing age with a negative pregnancy test documented prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
- Willing to use birth control if necessary.
- Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
Exclusion Criteria
- Pregnant or lactating.
- Positive for positive HIV or hepatitis C at baseline.
- Patients with coagulopathies, including thrombocytopenia with platelet count less than 75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.
- Major cardiac illness MUGA less than 50% EF.
- Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
Data sourced from ClinicalTrials.gov (NCT02063724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.