West Cancer Center

BREAST: Adjuvant; HER2 negative; Vaccine; "PRESENT"

PRESENT: Prevention of recurrence in early-stage, node-positive breast cancer with low to intermediate HER2 expressions with NeuVax treatment

Title

Galena PH3-01

Study Title

PRESENT: Prevention of recurrence in early-stage, node-positive breast cancer with low to intermediate HER2 expressions with NeuVax treatment

Site Link

NCT01479244

Malignancy

Breast, Early Breast Cancer

Stage

Stage 2

Disease Setting

Adjuvant

Line Of Therapy

Post-definitive (neo)adjuvant therapy

Investigational Agent

Neuvax (Nelipepimut-S or E75)

Drug Class

anti-tumor vaccine, active specific immunotherapy

Lee Schwartzberg, MD

Sponsor

Galena BioPharma

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01479244?term=Galena+PH3-01&rank=1

Key Eligibility Criteria Details

HER2- (IHC1+ or IHC2+/ISH-)HLA-A2 or HLA-A3 positive haplotype
T1-3
Node positive
Had ALND if SNB+ at definitive surgery
Completed neoadj or adj chemotherapy
Completed radiation therapy (if indicated)_
No autoimmune disease
No chronic steroid use

Objective

Primary- DFS: Secondary- OS, TTR, TTLR, TTDR, TTBone mets

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

HER2 1+ or 2+ (ISH negative) HLA-A2 or HLA-A3 haplotype

Dosing Frequency

Neuvax + GM-CSF in 4 divided doses sub-Q qmonth x 6 doses

Control Agents

GM-CSF alone

Study Protocol

Randomized

Yes