HER3 - primed Dendritic cells for erbB-2 Receptor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Moffitt Cancer Center, Tampa, FL
erbB-2 Receptor+3 More
HER3 - primed Dendritic cells - Biological
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

1 of 3

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

1 of 3

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
Photo of moffitt cancer center 1Photo of moffitt cancer center 2Photo of moffitt cancer center 3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.