Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Apr 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for people with HER2-positive breast cancer, which is a specific type of breast cancer that tends to grow faster. The researchers want to see if adding a special vaccine called the Dendritic Cell (DC1) vaccine to standard chemotherapy (which includes drugs like Paclitaxel, Trastuzumab, and Pertuzumab) can improve treatment outcomes. This trial is in Phase 2, meaning it's moving beyond initial safety testing to see how effective the treatment can be.

To join the study, participants must be adults aged 18 or older with a confirmed diagnosis of early-stage HER2-positive breast cancer that is at least 1 cm in size. They should be planning to receive the standard chemotherapy before surgery. Those interested should be in good overall health and not have other serious health conditions that could interfere with the study. Participants will receive the combination of the vaccine and chemotherapy, and their progress will be closely monitored throughout the trial. It’s important for potential participants to understand that they must agree to use birth control during the study and cannot be pregnant or breastfeeding.

Gender

ALL

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).