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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no cancer history except for certain skin cancers, cervical cancer in situ, or any cancer I've been free from for 3+ years.My tumor is either not hormone receptor positive or has low hormone receptor positivity.I have not received a live vaccine in the last 30 days.I have been treated with a therapy targeting HER2 or HER3 before.My breast cancer is in an early to mid-stage, with some lymph node involvement.I have received anthracycline-based chemotherapy before.I have an autoimmune disease that could come back or affects my organs.My doctor agrees I can have chemotherapy before surgery.I am not pregnant or nursing.I am 18 years old or older.I am using two forms of birth control and my pregnancy test was negative.I have tested positive for HIV/AIDS.I have not had breast cancer vaccine treatments in the last 3 months.I am fully active or can carry out light work.I have inflammatory breast cancer.My breast cancer is not HER2-positive.I am not currently on any experimental drugs or cancer treatments.I am using effective birth control and not pregnant if I can have children.I do not have any severe illnesses or mental health issues that would stop me from following the study's requirements.My breast cancer is in an early to mid-stage, with some lymph node involvement.My tumor is either not hormone receptor positive or has low hormone receptor positivity.My breast cancer is not HER2-positive.
Research Study Groups:
This trial has the following groups:- Group 1: Dendritic Cell Vaccine dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.