Actively Recruiting
Phase II Study of HER2-Directed Dendritic Cell DC1 Vaccine with Paclitaxel, Trastuzumab, and Pertuzumab in HER2-Positive Breast Cancer
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-02
53
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
I
ImmunoRestoration
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether adding an investigational Dendritic Cell DC1 vaccine to standard pre-surgery therapy can help people with HER2-positive breast cancer. This phase II study focuses on evaluating the immune response and the effectiveness of the vaccine combined with chemotherapy and targeted drugs in patients with confirmed HER2-positive invasive breast cancer. Participants receive the HER2-directed DC1 vaccine weekly for 6 weeks, with booster shots at months 6, 9, and 12. The treatment also includes weekly paclitaxel from weeks 7 to 18, along with trastuzumab and pertuzumab given intravenously every 3 weeks. After these treatments, participants undergo standard surgery to remove the tumor. The study includes dose escalation phases and expansions based on safety and response. During the study, participants undergo regular assessments including imaging to measure tumor response, immune system monitoring, and evaluations for safety and side effects. The main outcomes are immune response at 4 weeks and the rate of complete tumor removal at 12 months. Participants are followed for up to 5 years to track recurrence-free survival. The total trial duration includes treatment, booster vaccinations, surgery, and long-term follow-up.
CONDITIONS
Brief Title
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed clinical stage I-III HER2-positive invasive breast cancer with a primary tumor of at least 1 cm
- Candidate for neoadjuvant chemotherapy including paclitaxel, trastuzumab, and pertuzumab followed by standard local therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Normal organ and marrow function as defined by the protocol
- Cardiac ejection fraction within normal institutional limits by MUGA scan or echocardiogram at baseline
- Women of child-bearing potential and male partners must agree to use adequate contraception during the study
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Inflammatory breast cancer or unresectable locally advanced disease involving chest wall or nodal basins
- Suspected or confirmed metastatic disease at diagnosis
- Receiving other investigational treatments for breast cancer
- History of allergic reactions to vaccine components or chemotherapy drugs (paclitaxel, trastuzumab, pertuzumab)
- Unwilling or unable to undergo apheresis for vaccine production
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Pregnant or breastfeeding women
- Known congenital or acquired immune deficiency or requiring systemic immunosuppressants
Research Team
N
Neveen Abdo
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