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

Phase 3
18 Years
Open (Enrolling)
HER2 Negative Breast Cancer

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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.


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.


Inclusion Criteria:

- Women, 18 years of age and higher

- Pathological diagnosis of invasive adenocarcinoma of the breast

- Breast cancer completely excised

- Node-positive disease

- Primary tumor stage T1-3

- HER2 negative (HER2 1+ by IHC or HER2 2+ by IHC/FISH)

- HLA-A2 or HLA-A3 haplotype

- Completed NCCN approved neo-adjuvant/adjuvant chemotherapy or both

- Completed radiation therapy

- No evidence of disease

Key Exclusion Criteria:

- Bilateral breast malignancy or suspicious mass in opposite breast

- History of prior breast cancer, ductal carcinoma in situ.

- Prior trastuzumab therapy.

- New York Heart Association Stage 3 or 4 cardiac disease

- Sensory/motor neuropathy ≥ Grade 2.

- Autoimmune diseases or immune deficiency disease

- Patients on chronic steroid therapy, other immunosuppressive therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Comparison of disease-free survival in vaccine treated patients and control patients

Outcome Description:

The primary objective is to compare the disease-free survival (DFS) in subjects with operable early-stage, node-positive breast cancer who receive standard of care multimodality therapy plus NeuVax™ as the treatment group or standard of care multimodality therapy plus the vaccine adjuvant, Leukine (sargramostim, GM-CSF) as the control group.

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Elizabeth A Mittendorf, MD,FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:

NeuVax(TM) PH3-01



Start Date:

November 2011

Completion Date:

May 2022

Related Keywords:

  • HER2 Negative Breast Cancer
  • HER2
  • low or intermediate
  • breast cancer
  • node-positive tumors
  • Breast Neoplasms
  • Recurrence



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