Prevention of Recurrence in Early-Stage,Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax(TM) Treatment

Trial Information

Prevention of Recurrence in Early-Stage,Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax(TM) Treatment

This is a multicenter, multinational, prospective, randomized, double-blind, controlled
Phase 3 study.

The subjects eligible for this trial have an early stage Node-Positive (NP) breast cancer.
Their tumors express low or intermediate levels of the HER2 protein. NeuVax™ will be
administered after completion of front-line, standard of care therapy (surgery, radiation
therapy, and chemotherapy) and can be given with physician prescribed endocrine treatment.

The NeuVax will be administered in intradermal injections, in four divided doses (4 sites on
upper thigh) once a month, for six consecutive months. At the end of the six months, NeuVax
vaccine boosters will be given the same way once every six months for the next five times
(totaling 36 months).

The active portion of the study will last three years (36 months). The follow-up will last
from 5 to 10 years.

Endpoints:

1. The primary efficacy endpoint is comparing Disease-Free Survival (DFS) in treatment
group versus control group.

2. The secondary efficacy endpoints are

- 5- and 10-year (disease free survival) DFS

- 3-year overall survival (OS)

- 5- and 10-year overall survival (OS), and Overall safety profile and adverse
events (AEs)

Safety Assessments:

Patients will be assessed at every study visit for the safety endpoints AEs,vital signs,
physical examinations and laboratory data; yearly follow-up of survival will include imaging
studies, ECGs, MUGA or ECHO scans and concomitant medications.