HER3 - primed Dendritic cells for erbB-2 Receptor
Phase-Based Progress Estimates
Effectiveness
Safety
Moffitt Cancer Center, Tampa, FL
erbB-2 Receptor+3 More
HER3 - primed Dendritic cells - BiologicalEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer.
Eligible Conditions
- Breast Cancer (Triple Negative Breast Cancer (TNBC))
- erbB-2 Receptor
Treatment Effectiveness
Effectiveness Progress
Other trials for erbB-2 Receptor
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Up to 36 Months
Week 4
Maximum Tolerated Dose (MTD)
Week 5
Number of Dose Limiting Toxicities
Up to 24 weeks
Participants with pathological complete response after receiving HER2/HER3 DC1 intratumoral injections
Up to 36 Months
Participants with Recurrence Free Survival (RFS)
Participants with clinical and radiological partial responses after receiving HER2/HER3 DC1
Participants with clinical and radiological progression of disease after receiving HER2/HER3 DC1
Participants with clinical and radiological responses after receiving HER2/HER3 DC1
Participants with clinical and radiological stable disease after receiving HER2/HER3 DC1
Trial Safety
Safety Progress
Other trials for erbB-2 Receptor
Trial Design
1 Treatment Group
Dendritic Cell Vaccine dose Escalation
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: HER3 - primed Dendritic cells · No Placebo Group · Phase 1
Dendritic Cell Vaccine dose EscalationExperimental Group · 2 Interventions: HER2 - primed Dendritic cells, HER3 - primed Dendritic cells · Intervention Types: Biological, Biological
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
Closest Location: Moffitt Cancer Center · Tampa, FL
2009First Recorded Clinical Trial
0 TrialsResearching erbB-2 Receptor
222 CompletedClinical Trials
Who is running the clinical trial?
The Shulas' FoundationUNKNOWN
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
486 Previous Clinical Trials
123,372 Total Patients Enrolled
Ricardo Costa, MDPrincipal InvestigatorMoffitt Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a diagnosis of HR negative or HR low positive tumor.
You have breast cancer that is not in the early stages.
You are medically and surgically appropriate to undergo neoadjuvant chemotherapy regimen followed by standard of care local therapy as determined by your treating physician.
You have an absolute neutrophil count (ANC) of at least 1500/μL.
You have a total bilirubin level of 1.5 to 3.0 mg/dL.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments