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Cancer Vaccine

Dendritic Cell Vaccine for Breast Cancer (DecipHER Trial)

Tampa, FL
Phase 1
Recruiting
Led By Ricardo Costa, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether an investigational vaccine can help people with certain types of breast cancer when given alongside standard chemotherapy drugs.

See full description
Who is the study for?
This trial is for adults over 18 with early-stage Triple Negative or HR low positive breast cancer, who can undergo standard chemotherapy and surgery. Participants need normal organ/marrow function, no severe autoimmune diseases, not pregnant/nursing, and no recent vaccines or other cancer treatments.
What is being tested?
The DecipHER Trial tests if a new vaccine made from Dendritic cells (immune cells) primed against HER3/HER2 proteins can boost the effectiveness of standard chemo in treating certain breast cancers.See study design
What are the potential side effects?
Potential side effects may include typical immune responses like fever or fatigue as well as site reactions where the vaccine was given. Since it involves the immune system, there might be a risk of autoimmunity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD)
Secondary study objectives
Number of Dose Limiting Toxicities
Participants with Recurrence Free Survival (RFS)
Participants with clinical and radiological partial responses after receiving HER2/HER3 DC1
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dendritic Cell Vaccine dose EscalationExperimental Treatment2 Interventions
Dose escalation to determine the maximum tolerated dose (MTD) of HER2- and HER3- primed DC1 study vaccines. Participants will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 3 dose levels will be used.

Find a Location

Closest Location:Moffitt Cancer Center· Tampa, FL

Who is running the clinical trial?

The Shulas' FoundationUNKNOWN
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
567 Previous Clinical Trials
144,889 Total Patients Enrolled
41 Trials studying Breast Cancer
4,096 Patients Enrolled for Breast Cancer
Ricardo Costa, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

HER2-primed Dendritic cells (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05504707 — Phase 1
Breast Cancer Research Study Groups: Dendritic Cell Vaccine dose Escalation
Breast Cancer Clinical Trial 2023: HER2-primed Dendritic cells Highlights & Side Effects. Trial Name: NCT05504707 — Phase 1
HER2-primed Dendritic cells (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05504707 — Phase 1
~9 spots leftby Jan 2026