HER2-targeted vaccine combined with standard chemotherapy for breast cancer

A Phase II Study of Human Epidermal Growth Factor Receptor 2 (HER-2) Directed Dendritic Cell (DC1) Vaccine Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer

This study is testing if adding a new vaccine to standard chemotherapy can help people with HER2-positive breast cancer have better treatment results.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (other)
• Drugs / interventions: Trastuzumab, Pertuzumab, chemotherapy
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT05325632 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of an investigational Dendritic Cell (DC1) vaccine when added to standard neoadjuvant therapy, which includes Paclitaxel, Trastuzumab, and Pertuzumab, for patients with HER2-positive breast cancer. Participants will receive the vaccine alongside the chemotherapy regimen before undergoing standard local therapy. The goal is to determine if this combination can improve treatment outcomes for patients with this specific type of breast cancer.

Who should consider this trial

Good fit: Ideal candidates are women with histologically confirmed stage I-III HER2-positive invasive breast cancer who are eligible for neoadjuvant chemotherapy.

Not a fit: Patients with non-HER2-positive breast cancer or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the effectiveness of existing treatments for HER2-positive breast cancer, potentially leading to better patient outcomes.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in HER2-positive breast cancer, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* 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
* Candidate for neoadjuvant chemotherapy with Paclitaxel, Trastuzumab, Pertuzumab regimen followed by standard of care local therapy as determined by the treating physician
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Participants must have normal organ and marrow function as defined per protocol.
* Cardiac ejection fraction within institutional normal limits by either Multigated Acquisition Scan (MUGA) or Echocardiogram at baseline.
* Women of child-bearing potential and their male partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Sexually active male participants should use a barrier method or exercise abstinence during chemotherapy administration until surgery.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants with inflammatory breast cancer, widespread locally advanced unresectable disease involving the chest wall/nodal basins in which a curative surgical resection cannot be performed, or those in whom de novo metastatic disease is suspected or confirmed.
* Patients may not be receiving any other investigational agents for the treatment of their breast cancer.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study vaccine components and any of the chemotherapy drugs (paclitaxel, trastuzumab, pertuzumab).
* Participants who are unwilling or unable to undergo an apheresis for production of their vaccine.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women and women who are breastfeeding.
* Participants with known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant).

Where this trial is running

Tampa, Florida

• Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Hyo (Heather) Han, MD — Moffitt Cancer Center
• Study coordinator: Neveen Abdo

Conditions: HER2-positive Breast Cancer, Breast Cancer