Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials ID:NCT03384914
This study is testing two different vaccines to see if they can safely help prevent the return of HER-2 positive breast cancer after treatment. Participants will receive one of the two vaccines in two phases: an initial vaccination phase and a booster phase.
Patient Parameters
| Parameter | Options |
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Program Overview
The main goal of this study is to check the safety of two vaccines and see how they affect the time it takes for HER-2 positive breast cancer to come back. Participants will be randomly assigned to receive either the DC1 study vaccine or WOKVAC. The vaccines will be given in two stages: an initial vaccination phase and a booster phase. The study will last for 6 years, with 4 years for enrolling patients and 2 years for follow-up. Every 6 months, participants will be checked for any signs of cancer returning, either through phone calls, secure emails, medical records, or follow-up visits.
Description
The study will last a total of 6 years, with 4 years dedicated to enrolling patients and 2 additional years for follow-up. During the follow-up period, participants will be monitored every 6 months to check for any signs of cancer returning. This will be done through phone calls, secure emails, medical records, or follow-up visits. The follow-up will continue until the study ends or until the cancer returns.
Eligibility Criteria
Inclusion Criteria
- Have stage I-III HER2 positive breast cancer treated with chemotherapy and HER-2 targeted treatment for at least 12 weeks.
- Have remaining cancer in the breast or lymph nodes after chemotherapy.
- Finished last cycle of chemotherapy or radiation more than 30 days ago, with recovery from side effects.
- Currently receiving or recently completed HER-2 targeted therapy.
- Be 18 years or older.
- Be in good overall health with an ECOG performance status of 0 or 1.
- Have normal organ and bone marrow function, as shown by specific blood tests.
- Have a normal heart function test within 90 days before joining the study.
- Women who can have children must use two forms of birth control and have a negative pregnancy test before starting the study. Men must use effective birth control if their partner can have children. Both men and women must continue using birth control during the study and for three months after the last dose.
- Be able to understand and willing to sign a consent form before starting any study procedures.
Exclusion Criteria
- Have uncontrolled health issues like ongoing infections, heart problems, or psychiatric conditions that would make it hard to follow the study.
- Have an autoimmune disease that needs active treatment.
- Have an allergy to the GM-CSF adjuvant used in the vaccine.
- Be pregnant or breastfeeding.
- Be HIV-positive.
- Have a current or past hepatitis B or C infection unless it has been treated and cleared.
- Had major surgery within 4 weeks before starting the study.
- Be using long-term immunosuppressive drugs or systemic corticosteroids, except for certain allowed uses.
- Be participating in another clinical trial involving experimental treatments or devices.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | 33612 | Tampa | Florida |
| Emory - Winship Cancer Institute | 30322 | Atlanta | Georgia |
| Indiana University - Melvin and Bren Simon Cancer Center | 46202 | Indianapolis | Indiana |
| Rutgers Cancer Institute of New Jersey | 08903 | New Brunswick | New Jersey |
| Roswell Park Comprehensive Cancer Center | 14263 | Buffalo | New York |
| Ohio State University - Arthur G James Cancer Hospital & Richard J Solove Research Institute | 43210 | Columbus | Ohio |
| University of Washington, Fred Hutchinson Cancer Research Center | 98109 | Seattle | Washington |
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