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Cancer Vaccine

Dendritic Cell Vaccine for Breast Cancer

Phase < 1

Waitlist Available

Led By Haten Soliman, M.D.

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

Medically and surgically appropriate to undergo neoadjuvant chemotherapy with TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) regimen followed by standard of care local therapy as determined by their treating physician

Age ≥18 years

Must not have

Known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant)

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study vaccine components and any of the chemotherapy drugs (docetaxel, carboplatin, trastuzumab, pertuzumab)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether the DC1 study vaccine can help the participant's immune system make antibodies and T cells (a type of white blood cell) that will react to and kill HER2-positive breast cancer cells.

Who is the study for?

This trial is for adults with stage II or III HER2+ invasive breast cancer, who are in good health otherwise, with normal organ and marrow function. They must not be pregnant or breastfeeding, have no severe illnesses that could affect study participation, and agree to use contraception. It's not for those with inflammatory breast cancer, uncontrolled diseases like heart failure or arrhythmias, immune deficiencies, certain allergies to vaccine components or chemotherapy drugs.

What is being tested?

The trial tests a new type of treatment called DC1 dendritic cell vaccine alongside standard neoadjuvant chemotherapy (TCH-P regimen) before surgery. The DC1 vaccine is made from the patient's own blood cells and aims to boost the immune system to fight breast cancer more effectively.

What are the potential side effects?

Potential side effects include typical reactions related to vaccines such as pain at injection site, fever and fatigue; plus those associated with chemotherapy like nausea, hair loss, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My doctor agrees I can have specific chemotherapy and follow-up care.

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I am 18 years old or older.

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My breast cancer is at stage II or III, ERPR-negative, and HER2-positive.

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I am mostly self-sufficient and can carry out daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an immune deficiency or take drugs to suppress my immune system.

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I am not allergic to the study vaccine or similar chemotherapy drugs.

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I have nerve damage that prevents me from receiving certain chemotherapy drugs.

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My breast cancer cannot be removed by surgery due to its spread or severity.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I cannot or do not want to undergo a procedure to collect my cells for a vaccine.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Expansion Phase Schedule Selection by Week 4

Pathologic Complete Response (pCR) Rate

Secondary study objectives

Recurrence Free Survival (RFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Expansion PhaseExperimental Treatment3 Interventions

DC1 vaccinations according to optimal vaccination schedule. Participants will receive a booster intranodal study vaccine at week 25 prior to receiving surgery. Participants will then undergo definitive curative surgery following completion of the neoadjuvant therapy, additional adjuvant locoregional/systemic therapy (as deemed appropriate by their treating physicians).

Group II: Lead In Phase - Arm AActive Control3 Interventions

Arm A: One Dendritic Cell Vaccine (DC1) per week x 3 weeks.

Group III: Lead In Phase - Arm BActive Control3 Interventions

Arm B: Two DC1 vaccinations per week (given 3 days apart i.e., Mon and Thurs or Tues and Friday) x 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neoadjuvant Chemotherapy

2014

Completed Phase 2

~340