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Cancer Vaccine

Dendritic Cell Vaccine for Breast Cancer (DecipHER Trial)

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
Patients must have normal organ and marrow function within 14 days of registration: ANC ≥ 1500/μL, Platelets ≥ 75 000/μL, Total bilirubin ≤ 1.5 x institutional ULN (except patients with Gilbert's syndrome), AST/ALT ≤ 3 x institutional ULN, Creatinine ≤ 1.5 x institutional ULN, Left ventricular ejection fraction above institutional lower limit of normal
ECOG performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

DecipHER Trial Summary

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

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.Check my eligibility
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.

DecipHER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My tumor is either not hormone receptor positive or has low hormone receptor positivity.
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My breast cancer is not HER2-positive.
Select...
My breast cancer is in an early to mid-stage, with some lymph node involvement.
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I am 18 years old or older.
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I am using two forms of birth control and my pregnancy test was negative.

DecipHER Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
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

DecipHER 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

Who is running the clinical trial?

The Shulas' FoundationUNKNOWN
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
540 Previous Clinical Trials
135,405 Total Patients Enrolled
41 Trials studying Breast Cancer
5,780 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to volunteer for this study?

"The clinical trial is still in need of participants, as evidenced by the recent update posted on August 15th 2022. This study was initially publicized on 8/11/2022."

Answered by AI

Has the FDA sanctioned using HER3 - primed Dendritic cells in treatments?

"This treatment has limited clinical data supporting both safety and efficacy, thus Power rated HER3 - primed Dendritic cells a 1 on the scale."

Answered by AI

What is the full breadth of participants who are enrolled in this clinical research?

"That is correct. Clinicaltrials.gov has evidence that this clinical trial, first published on August 11th 2022, is still recruiting participants. 30 individuals are needed at just a single research site to complete the experiment."

Answered by AI

Who else is applying?

What site did they apply to?
Moffitt Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Apr 2024