Welcome to our deep dive on the ongoing breast cancer vaccine study, formally known as the “Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer”.
This study is slated to conclude in 2026, and has the main purpose of:
- Evaluating the safety of the study vaccine
- Evaluating the time to cancer recurrence
The vaccine study currently has 119 enrolled participants, and is observing both male and female subjects who:
- Are 18 and older
- Have been diagnosed with clinical stage I-III HER2 positive breast cancer and have been treated with neoadjuvant chemotherapy for at least 12 weeks prior
- Have completed their last cycle of cytotoxic chemotherapy
- Are currently on HER2 targeted therapy
The Phase II study details are as follows:
- The study will last a total of 6 years; 4 years of enrollment followed by 2 years of follow-up
- During the follow-up years, assessment for disease recurrence will be measured every 6 months
- Assessment for recurrence will be measured via cell phone, secure mail, medical records or follow-up visits
The study design includes both vaccination and booster visits:
- All subjects will be assigned 1 of 2 study vaccinations; either DC1 study vaccine or WOKVAC
- The first booster will be administered 6 months after 1st vaccination
- Subjects will receive a total of 3 boosters
This study is taking place only within the United States, in locations including:
- Florida
- Georgia
- Indiana
- New Jersey
- New York
- Ohio
- Washington
While this study is still ongoing and will continue to progress until 2026, the results of preliminary studies have given immense hope to the medical and breast cancer communities alike.
Follow along to stay updated on study findings and results!