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Efficacy and Safety Study of NeuVax(TM)(Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)

This study is currently recruiting participants.
Verified May 2013 by Galena Biopharma, Inc.
Sponsor:
Information provided by (Responsible Party):
Galena Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT01479244
First received: November 20, 2011
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

Purpose of this trial:

  1. To assess the efficacy and safety of NeuVax(TM)a peptide (E75) vaccine administered with adjuvant Leukine(R)(sargramostim,GM-CSF).
  2. To evaluate and compare the disease free survival (DFS) in the vaccinated patients and control patients.

Condition Intervention Phase
HER2 Negative Breast Cancer
 Biological: NeuVax vaccine
Biological: Leukine (sargramostim, GM-CSF) and water for injection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Recurrence in Early-Stage,Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax(TM) Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Galena Biopharma, Inc.:

Primary Outcome Measures:
  • Comparison of disease-free survival in vaccine treated patients and control patients [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Assessment of Disease-Free Survival and Overall Survival at 3, 5 and 10 years in vaccine and control groups, respectively; assessment of safety [ Time Frame: 3 through 10 years ] [ Designated as safety issue: Yes ]

    The secondary objectives are to evaluate the 2 groups of subjects for:

    • 5- and 10-year DFS
    • 3-year Overall survival (OS)
    • 5- and 10-year OS
    • Time to recurrence (TTR), time to local recurrence (TTLR), time to distant recurrence (TTDR), time to bone metastases (TTBM)
    • Overall safety profile and adverse events (AEs)


Estimated Enrollment: 700
Study Start Date: November 2011
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NeuVax vaccine
NeuVax [E75 acetate in WFI solution with Leukine(R)(sargramostim,GM-CSF)
 Biological: NeuVax vaccine
E75 peptide acetate (HER2/neu p366-379) in Water for Injection (WFI, 1.5 mg/mL mixed with 250 microgram Leukine (sargramostim, GM-CSF), for intradermal injections administered once a month for six months, followed by booster inoculations administered once every six months for five additional injections.
Other Name: E75 peptide acetate , WFI, sargramostim, GM-CSF
Active Comparator: Control
Control: Leukine(GM-CSF, sargramostim)with Water for injection
 Biological: Leukine (sargramostim, GM-CSF) and water for injection
Leukine 250 microgram in water for injection, monthly intradermal injections for six months, followed by booster inoculations administered once every six months for five additional injections.
Other Name: Leukine(R)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479244

Contacts
Contact: Lynn Sutton, RN, MA +1 855.855.4253 ext 113 lsutton@galenabiopharma.com
Contact: Allan A Valmonte +1.503.400.6624 avalmonte@galenabiopharma.com

  Show 106 Study Locations
Sponsors and Collaborators
Galena Biopharma, Inc.
Investigators
Principal Investigator: Elizabeth A Mittendorf, MD,FACS M.D. Anderson Cancer Center
  More Information

Additional Information:
Sponsor website  This link exits the ClinicalTrials.gov site
Vaccine site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Galena Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT01479244     History of Changes
Other Study ID Numbers: NeuVax(TM) PH3-01
Study First Received: November 20, 2011
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Galena Biopharma, Inc.:
HER2
low or intermediate
breast cancer
node-positive tumors

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013