Phase II Study of WOKVAC Vaccine with Chemotherapy and HER2-Targeted Antibody Therapy Before Surgery for HER2-Positive Breast Cancer

What this Trial Is About

Researchers are studying the immune response and side effects of the WOKVAC vaccine combined with chemotherapy and HER2-targeted antibody therapy before surgery in patients with breast cancer. This phase II trial focuses on patients with stages I to III HER2-positive breast cancer, aiming to enhance the bodys ability to attack tumor cells by using these treatments together. The study evaluates whether adding WOKVAC to standard therapies like paclitaxel, trastuzumab, and pertuzumab can improve tumor cell destruction before surgery. Participants receive the WOKVAC vaccine injected into the skin on day 13, repeated up to three times if the disease does not progress and side effects are manageable. Alongside, they receive chemotherapy drugs including paclitaxel infusions on days 1, 8, and 15 or a combination of docetaxel and carboplatin on day 1, plus trastuzumab and pertuzumab infusions on day 1. Chemotherapy and antibody treatments are typically given by the participants oncologist following standard care. Treatment cycles can be repeated up to four times, with patients undergoing imaging scans and biopsies during the study. Throughout the trial, participants provide blood samples and undergo ultrasound or magnetic resonance imaging to monitor their response. Researchers measure immune cells in tumor tissue after treatment and track side effects for up to five years. After completing treatment, patients are followed annually for up to five years to observe long-term outcomes and safety. The total participation time varies depending on individual treatment and follow-up schedules.

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer