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Anti-microtubule agent
HER2 DC1 Vaccine + Chemotherapy for Breast Cancer
Phase 2
Recruiting
Led By Hyo (Heather) Han, 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
Participants must have normal organ and marrow function as defined per protocol
Participants must have histologically confirmed clinical stage I- III, HER2+ (per ASCO/CAP criteria) invasive carcinoma of the breast. Primary tumor should measure at least 1 cm by clinical exam or radiologic tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new vaccine to see if it can help people with a specific type of breast cancer.
Who is the study for?
This trial is for adults with stage I-III HER2+ breast cancer, measurable by exam or imaging. They must be fit for neoadjuvant chemo and surgery, have good organ function, not be pregnant or breastfeeding, agree to use contraception, and have a normal heart ejection fraction. Excluded are those on other trials, with inflammatory/unresectable/metastatic breast cancer, allergies to similar drugs/vaccine components, immune deficiencies requiring suppressants, unable to undergo apheresis or with uncontrolled illnesses.Check my eligibility
What is being tested?
The study tests if adding a Dendritic Cell (DC1) vaccine to standard pre-surgery therapy (Paclitaxel/Trastuzumab/Pertuzumab) benefits patients with HER2+ breast cancer. Participants will receive this combination before their main treatment which includes resection surgery.See study design
What are the potential side effects?
Possible side effects include reactions at the vaccine injection site; common chemotherapy-related issues like nausea and hair loss; infusion reactions from Trastuzumab and Pertuzumab; potential impact on blood cell counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organs and bone marrow are functioning normally.
Select...
My breast cancer is stage I-III, HER2 positive, and the tumor is at least 1 cm big.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate
Lead in Phase: Immunogenicity of each dose level
Secondary outcome measures
Expansion Phase: Immunogenicity
Expansion Phase: Radiologic tumor response rate after 6 weeks
Expansion Phase: Radiologic tumor response rate at completion of therapy
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Lead In: Dose Level 2Experimental Treatment5 Interventions
Six participants will be treated at dose level 2: DC vaccine given at the dose of 100 million once per week for 6 weeks
Group II: Lead In - Dose level 1Experimental Treatment5 Interventions
Six participants will be treated at dose level 1: DC vaccine given at the dose of 50 million once per week for 6 weeks
Group III: Expansion -Estrogen Receptor (ER) positiveExperimental Treatment5 Interventions
An additional 24 participants will be enrolled at dose level 2 if determined to be safe in lead in phase to have a total of 28 evaluable participants for pathologic response assessment (including 6 pts from the lead in phase).
Group IV: Expansion -Estrogen Receptor (ER) negativeExperimental Treatment5 Interventions
An additional 23 participants will be enrolled at dose level 2 if determined to be safe in lead in phase to have a total of 28 evaluable participants for pathologic response assessment (including 6 pts from the lead in phase).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Pertuzumab
FDA approved
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,439 Total Patients Enrolled
41 Trials studying Breast Cancer
5,780 Patients Enrolled for Breast Cancer
ImmunoRestorationIndustry Sponsor
Hyo (Heather) Han, MDPrincipal InvestigatorMoffitt Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer cannot be surgically removed or has spread from where it started.I have an immune deficiency or take drugs to suppress my immune system.I am not allergic to the study vaccine or similar chemotherapy drugs.I agree to use birth control or abstain from sex during the study.My organs and bone marrow are functioning normally.My breast cancer is stage I-III, HER2 positive, and the tumor is at least 1 cm big.I am willing and able to undergo apheresis for vaccine production.My doctor has approved me for a specific chemotherapy treatment before surgery.I am fully active or can carry out light work.Your heart's pumping ability is within the normal range, as shown on a heart scan or ultrasound.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Lead In - Dose level 1
- Group 2: Lead In: Dose Level 2
- Group 3: Expansion -Estrogen Receptor (ER) positive
- Group 4: Expansion -Estrogen Receptor (ER) negative
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you please compare the safety of HER-2 pulsed DC1 to other cancer treatments?
"Given that this is a Phase 2 trial, which only has data supporting safety and not efficacy, our team has given HER-2 pulsed DC1 a score of 2 for safety."
Answered by AI
Are people with the required conditions able to sign up for this trial right now?
"That is correct. The information available on clinicaltrials.gov does show that this study is recruiting patients. This trial was posted on November 1st, 2021 and was last edited on October 6th, 2022. A total of 34 patients are needed for this study that will take place at 1 location."
Answered by AI
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