Vaccine Therapy in Preventing Recurrence in Patients with Her-2 Positive Stage I-III Breast Cancer

Active:	No
Cancer Type:	Breast Cancer	NCT ID:	NCT03384914
Trial Phases:	Phase II	Protocol IDs:	MCC-19117 (primary) NCI-2018-00290
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Moffitt Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT03384914

Summary

This phase II trial studies the side effects and how well vaccine therapy works in preventing recurrence (return of breast cancer) in patients with HER-2 positive stage I-III breast cancer. Vaccines work by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer causing cell proteins.

Objectives

PRIMARY OBJECTIVES:
I. To evaluate safety and tolerability of each vaccine therapy.
II. To evaluate the immunogenicity following each vaccine therapy.

SECONDARY OBJECTIVE:
I. To determine disease free survival (DFS) of patients with HER2 positive breast cancer after treatment with each vaccine.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive HER2-pulsed autologous type-1 polarized dendritic cell vaccine (DC1) intranodally weekly in weeks 1-6. Patients receive booster vaccines at 6, 9, and 12 months.

ARM II: Patients receive pUMVC3-IGFBP2-HER2-IGF1R plasmid DNA vaccine (WOKVAC) intradermally in weeks 1, 4, and 7. Patients receive booster vaccines at 6, 9. and 12 months.

After completion of study treatment, patients are followed up every 6 months for up to 2 years.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.