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

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

Purpose of this trial:

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer With Low to Intermediate HER2 Expression
• Intervention / Treatment: Biological: NeuVax™ vaccine; Biological: Leukine® (sargramostim, GM-CSF) and water for injection

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 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 concomitantly with physician prescribed endocrine treatment.

NeuVax™ is the immmunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy through cell lysis HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of DFS, the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study.

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

Endpoints:

1. Primary efficacy endpoint:

   • 3-year DFS

2. Secondary efficacy endpoints:

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

Safety Assessments:

Subjects 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.

• Study Type: Interventional
• Enrollment (Actual): 758
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • Central Onco Hospital
  • Sofia, Bulgaria, 1303
    • Serdika
  • Sofia, Bulgaria, 1527
    • Tsaritsa Yoanna - ISUL
  • Tarnovo, Bulgaria, 5000
    • Complex Oncology Center, Veliko Tarnovo
  • Varna, Bulgaria, 9010
    • Sveta Marina
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G1Z2
      • Cross Cancer Institute
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Cancer Centre
    • Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North Cancer Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hospital Charles LeMorne
• Czech Republic
  • Brno, Czech Republic, 656 53
    • Masaryk Memorial Cancer Institute, Comprehensive Cancer Care Clinic
  • Hradec Kralove, Czech Republic, 500 05
    • University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy
  • Olomouc, Czech Republic, 775 20
    • University Hospital Olomouc, Clinic of Oncology
  • Prague 2, Czech Republic, 128 08
    • General University Hospital in Prague, Clinic of Oncology
• France
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Cedex 9
    • Angers, Cedex 9, France, 49933
      • Institut de Cancérologie de l'Ouest Siet Paul Papin
  • Lille
    • Cédex, Lille, France, 59020
      • Centre Oscar Lambret
  • Loire-Atlantique
    • St Herblain, Nantes Cedex, Loire-Atlantique, France, 44805
      • Institut de Cancérologie de l'Ouest/Rene Gauducheau
• Germany
  • Berlin, Germany, 10117
    • Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum
  • Bremen, Germany, 28177
    • Brustzentrum Klinikum Bremen-Mitte gGmbH
  • Erlangen, Germany, D-91054
    • Universitätsklinikum Erlangen, Frauenklinik
  • Essen, Germany, D-45136
    • Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Klinik für Senologie/Brustzentrum
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe
  • Heidelberg, Germany, 69120
    • Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig-Holstein, Campus Kiel
  • Marburg, Germany, 35043
    • Universität Marburg
  • Muenchen, Germany, 80637
    • Rotkreuzklinikum München gGmbH, Frauenklinik
  • Münster, Germany, 48149
    • Universitätsklinikum Münster, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
  • Stuttgart, Germany, 70374
    • Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik
  • Trier, Germany, 54290
    • Klinikum Mutterhaus der Borromaeerinnen
  • Wuerzburg, Germany, D-97080
    • Gemeinschaftspraxis für Innere Medizin, Haematologie und internistische Onkologie Dr. R Schlag/Dr. Schoettker
• Hungary
  • Budapest, Hungary, H-1032
    • Szent Margit Hospital, V. Department of Internal Medicine, Oncology
  • Budapest, Hungary, H-1083
    • Semmelweis University, Department of Diagnostic Radiology and Oncotherapy
  • Gyor, Hungary, H-9024
    • Petz Aladar County Teaching Hospital, Center for Oncoradiology
  • Kaposvar, Hungary, 7400
    • Kaposi Mor County Teaching Hospital, Center for Clinical Oncology
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen County Hospital and University Educational Hospital, Center for Clinical Oncology and Radiology
  • Jasz-Nagykun-Szolnok
    • Szolnok, Jasz-Nagykun-Szolnok, Hungary, H-5000
      • Hetenyi Geza Hospital, Department of Oncology
• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Petach Tikva, Israel, 49100
    • Rabin Medical Centre
  • Rehovot, Israel, 76100
    • Kaplan Medical Centre
  • Ramat Gan
    • Tel Hasomer, Ramat Gan, Israel, 52621
      • Sheba Medical Centre
• Poland
  • Gdynia, Poland, 81-519
    • Polish Red Cross Marine Hospital, Department of Chemotherapy
  • Lodz, Poland, 93-513
    • Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Chemotheraphy
  • Poznan, Poland, 61-866
    • Greater Poland Cancer Center, Department of Chemotherapy
  • Warsaw, Poland, 04-125
    • Magodent
  • Warsaw, Poland, 04-125
    • Non-Public Health Care Facility MAGODENT
  • Wroclaw
    • Kamienskiego, Wroclaw, Poland, 51-124
      • Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy
• Romania
  • Baia Mare, Maramures, Romania, 430031
    • Dr. Constantin Opris County Emergency Hospital, Department of Oncology
  • Bucharest, Romania, 011171
    • Filantropia Clinical Hospital, Obstetrics and Gynaecology Department
  • Bucharest, Romania, 030171
    • Coltea Clinical Hospital, Oncology Department
  • Bucharest, Romania, 050098
    • Bucharest Universtiy Emergency Hosptial, Oncology Department
  • Cluj-Napoca, Romania, 400015
    • "Prof. Dr. Ion Chiricuta" Institute of Oncology
  • Iasi, Romania, 700483
    • Iasi Regional Oncology Institute, Department of Medical Oncology
  • Timisoara, Romania, 300239
    • Oncomed SRL, Department of Medical Oncology
  • Bihor
    • Oradea, Bihor, Romania, 410469
      • "Gavril Curteanu" Municipal Clinical Hospital
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400058
      • Medisprof SRL, Department of Medical Oncology
  • Dolj County
    • Craiova, Dolj County, Romania, 200347
      • Oncology Center "Sf. Nectarie", Department of Medical Oncology
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk Clinical Oncology Center
  • Ekaterinburg, Russian Federation, 620036
    • Sverdlovsk Regional Oncology Center
  • Irkutsk, Russian Federation, 664035
    • Regional Oncology Center
  • Ivanovo, Russian Federation, 153040
    • Ivanovo Regional Oncology Center
  • Krasnodar, Russian Federation, 350040
    • Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration
  • Krasnoyarsk, Russian Federation, 660133
    • Krasnoyarsk Kryzhanovsky Regional Oncology Center
  • Kursk, Russian Federation, 305035
    • Kursk Regional Clinical Oncology Center
  • Moscow, Russian Federation, 115478
    • N.N. Blokhin Russian Cancer Research Center
  • Moscow, Russian Federation, 115478
    • N.N. Blokhin Russian Cancer Reserach Center
  • Nizhny Novgorod, Russian Federation, 603006
    • Clinical Diagnostics Center
  • Nizhny Novgorod, Russian Federation, 603081
    • Nizhny Novgorod Regional Oncology Center
  • Orel, Russian Federation, 302020
    • Orel Oncology Center
  • Orenburg, Russian Federation, 460051
    • Orenburg Regional Clinical Oncology Center
  • Ryazan, Russian Federation, 390011
    • Medical Institution of Ryazan Region
  • Samara, Russian Federation, 443031
    • Samara Regional Clinical Oncology Center
  • St Petersburg, Russian Federation, 197758
    • Petrov Research Institute of Oncology
  • St. Petersburg, Russian Federation, 191104
    • Leningrad Regional Oncology Center
  • St. Petersburg, Russian Federation, 194017
    • St. Petersburg Clinical Hospital
  • St. Petersburg, Russian Federation, 195067
    • Mechnikov North-Western State Medical University
  • St. Petersburg, Russian Federation, 198255
    • Municipal Clinical Oncology Center
  • Tambov, Russian Federation, 392013
    • Tambov Regional Clinical Oncology Center
  • Tomsk, Russian Federation, 634028
    • Research Institute of Oncology
  • Ufa, Russian Federation, 450000
    • Bashkir State Medical University
  • Veliky Novgorod, Russian Federation, 173016
    • Regional Clinical Oncology Center
  • Volzhskiy, Russian Federation, 404130
    • Volgograd Regional Oncology Center #3
  • Yaroslavl, Russian Federation, 150054
    • Yaroslavl Regional Oncology Center
  • Krasnodar
    • Sochi, Krasnodar, Russian Federation, 354057
      • Oncology Center #2, Department of Healthcare of Krasnodar Territory Administration
  • Republic of Mordovia
    • Saransk, Republic of Mordovia, Russian Federation, 430032
      • Republican Oncology Center
  • Republic of Tatarstan
    • Kazan, Republic of Tatarstan, Russian Federation, 420029
      • Republican Clinical Oncoogy Center
  • Stavropol Region
    • Pyatigorsk, Stavropol Region, Russian Federation, 357502
      • Pyatigorsk Oncology Center
• Ukraine
  • Chernivtsi, Ukraine, 58013
    • Chernivtsi Regional Clinical Oncology Center, Day Care Unit
  • Dnipropetrovsk, Ukraine, 49102
    • Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy
  • Donetsk, Ukraine, 83087
    • Donetsk City Oncology Center
  • Donetsk, Ukraine, 83092
    • Donetsk Regional Antitumor Center, Oncosurgery Department #2
  • Kharkiv, Ukraine, 61024
    • State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine
  • Kiev, Ukraine, 04107
    • Public Institution: Kiev Regional Oncology Hospital within Kyiv Regional Council
  • Kirovohrad, Ukraine, 25011
    • Kirovohrad Regional Oncology Center, Department of Mammology
  • Kyiv, Ukraine, 03115
    • Kyiv City Clinical Oncology Center, Department of Chemotherapy
  • Lviv, Ukraine, 79031
    • Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy
  • Odesa, Ukraine, 65000
    • Odesa Regional Clinical Hospital, Center for Mastology
  • Uzhhorod, Ukraine, 88014
    • Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy
  • Vinnytsia, Ukraine, 21029
    • Vinnytsia Regional Clinical Oncology Center
  • Zaporizhia, Ukraine, 69040
    • Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council
  • Autonomous Republic of Crimea
    • Simferopol, Autonomous Republic of Crimea, Ukraine, 95000
      • Clinical Diagnostics Center
  • Dnipropetrovsk Region
    • Kryvyi Rih, Dnipropetrovsk Region, Ukraine, 50000
      • Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy
  • Donetsk Region
    • Mariupol, Donetsk Region, Ukraine, 87500
      • Mariupol City Interdistrict Oncology Center, Surgery Department #2
  • Kyivskyi District
    • Kharkiv, Kyivskyi District, Ukraine, 61070
      • Kharkiv Regional Clinical Oncology Center, Day Care Unit
• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • Middlesborough, United Kingdom, TS4 3BW
    • James Cook University Hospital
  • Nottingham, United Kingdom, NG7 2UH
    • Academic Unit of Oncology, Nottingham University Hospital-City Campus
  • Plymouth, United Kingdom, PL6 8DH
    • Plymouth Oncology Centre, Derriford Hospital
  • Sheffield, United Kingdom, S10 2SJ
    • Weston Park Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Stoke on Trent, United Kingdom, ST4 6QG
    • University Hospital of North Staffordshire
  • Cheshire
    • Macclesfield, Cheshire, United Kingdom, SK10 3BL
      • Macclesfield District General Hospital
  • Manchester
    • Withington, Manchester, United Kingdom, M20 4BX
      • The Christie NHS Foundation Trust
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden NHS Foundation Trust
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Leeds Teaching Hospitals Trust, St. James University Hospital
• United States
  • Alabama
    • Bessemer, Alabama, United States, 35022
      • Alabama Oncology
    • Mobile, Alabama, United States, 36606
      • Physicians Pain Specialists of Alabama, P.C.
  • Arizona
    • Peoria, Arizona, United States, 83582
      • Pain Centers Nationwide
    • Scottsdale, Arizona, United States, 85254
      • Valley Pain Consultants
  • California
    • Burbank, California, United States, 91505
      • East Valley Hematology and Oncology medical Group
    • Carlsbad, California, United States, 92009
      • Coastal Pain Research
    • El Cajon, California, United States, 92020
      • Navajo Road Pain Management Center
    • Fresno, California, United States, 93720
      • California Cancer Associates for Research and Excellence
    • Fresno, California, United States, 93720
      • California Cancer Associates for Research and Excellence, Inc.
    • Fullerton, California, United States, 92801
      • St. Jude Medical Center, Virginia K. Crosson Cancer Center
    • Irvine, California, United States, 92618
      • Interventional Pain Management
    • Laguna Hills, California, United States, 92653
      • South Orange County Surgical Medical Group
    • Los Angeles, California, United States, 90033
      • University of Southern California/Norris Cancer Hospital
    • Los Angeles, California, United States, 90035
      • Alexander Ford, MD
    • Los Angeles, California, United States, 90036
      • Cancer Care Institute
    • Los Angeles, California, United States, 90036
      • Pete J. Ruane, MD, Inc.
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
    • San Diego, California, United States, 92093
      • Moores UC San Diego Cancer Center (UCSD)
    • San Francisco, California, United States, 94115
      • University of California, San Francisco (UCSF), Hellen Diller Family Comprehensive Cancer Center
    • Santa Monica, California, United States, 90404
      • Pain Institute of Santa Monica
    • Woodland Hills, California, United States, 91367
      • Randy Scharlach, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center, Anschutz Medical Campus
    • Golden, Colorado, United States, 80401
      • Red Rocks Center for Rehabilitation
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Western Connecticut Health Network, Danbury Hospital
    • Stamford, Connecticut, United States, 06904
      • Stamford Hospital, Bennett Cancer Center
    • Stamford, Connecticut, United States, 06905
      • Pain Management Associates of CT, PC
  • Florida
    • Aventura, Florida, United States, 33180
      • Innovative Medical Research of South Florida, Inc.
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida (ICON)
    • Orlando, Florida, United States, 32806
      • MD Anderson Center-Orlando Health
    • Plantation, Florida, United States, 33317
      • Florida Cancer Research Institute (Florida Cancer Care)
    • Plantation, Florida, United States, 33324
      • Florida Cancer Care
    • Tampa, Florida, United States, 33612
      • H.Lee Moffitt Cancer Center and Research Institute
  • Georgia
    • Athens, Georgia, United States, 30607
      • Northeast Georgia Cancer Care
    • Atlanta, Georgia, United States, 30309
      • Interventional Spine and Pain Management
    • Macon, Georgia, United States, 31201
      • Central Georgia Cancer Care
    • Newnan, Georgia, United States, 30265
      • Cancer Treatment Centers of America
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Pain Management Institute
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center, University of Louisville
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Cancer Center
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Center of Cancer and Blood Disorders (VEEDA network)
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Department of Hematology and Oncology
  • Michigan
    • Bay City, Michigan, United States, 48796
      • Physiatry Consultants
    • Brownstown, Michigan, United States, 48183
      • Michigan Interventional Pain Center
    • Royal Oak, Michigan, United States, 48071
      • William Beaumont Hospital Cancer Center
    • Saginaw, Michigan, United States, 48604
      • Glenn Saperstein, D.O., LLC
    • St. Clair Shores, Michigan, United States, 48080
      • Advanced Physical Medicine
  • New York
    • Bronx, New York, United States, 10469
      • Eastchester Cancer Care Center
    • New York, New York, United States, 10021
      • Fountain Medical Group
    • New York, New York, United States, 100665
      • Weill Cornell Medical College
    • New York, New York, United States, 36607
      • Upper East Side Pain Medicine, P.C.
    • Syosset, New York, United States, 11791
      • Comprehensive Pain Management
    • Williamsville, New York, United States, 14221
      • APWI
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • St. Alexius Medical Center, Mid Dakota Clinic, PC
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron General Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Cancer Treatment Centers of America
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute
  • Pennsylvania
    • Gettysburgh, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
    • Johnstown, Pennsylvania, United States, 15905
      • Conemaugh Memorial Hospital-Memorial Medical Center
    • New Castle, Pennsylvania, United States, 16101
      • J. Fred Stoner, MD
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center (UPMC) Cancer Center
    • Wind Gap, Pennsylvania, United States, 18091
      • Progressive Pain Solutions
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Jerrold Rosenberg, MD
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic Comprehensive Breast Center
    • Memphis, Tennessee, United States, 38120
      • The West Clinic
  • Texas
    • Dallas, Texas, United States, 75235
      • PRIDE
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center / Simmons Comprehensive Cancer Center
    • Ft. Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center (now SAMMC)
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc
    • San Antonio, Texas, United States, 78229
      • Cancer Care Centers of South Texas
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute Research
    • Tacoma, Washington, United States, 98405
      • Multicare Health System-Research Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 52336
      • Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Key Inclusion Criteria:

• Pathological diagnosis of invasive adenocarcinoma of the breast
• Breast cancer completely excised, or patient receiving neoadjuvant therapy prior to surgery

• One of these 2 surgical treatments and axillary staging with sentinel lymph node dissection or axillary dissection level I/II:

  1. Total mastectomy-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II
  2. BCS (lumpectomy)-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes
• Node-positive disease
• Primary tumor stage T1-3 at initial diagnosis
• 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
• Able and willing (or have legal representative) to understand the study and provide consent

Key Exclusion Criteria:

• Bilateral breast malignancy or suspicious mass in opposite breast
• Inflammatory breast malignancy
• 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
• Subjects on chronic steroid therapy, other immunosuppressive therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NeuVax™; NeuVax™ in WFI solution with Leukine®	Biological: NeuVax™ vaccine; E75 peptide acetate (HER2/neu p366-379) in WFI (1.5 mg/mL) mixed with 250 micrograms Leukine® (sargramostim, GM-CSF), 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).; Other Names: E75 peptide acetate , WFI, sargramostim, GM-CSF
Active Comparator: Leukine®; Leukine® with WFI	Biological: Leukine® (sargramostim, GM-CSF) and water for injection; Leukine® 250 micrograms in water for injection, 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, boosters inoculations will be given the same way once every six months for the next five times (totaling 36 months).; Other Names: Leukine®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of DFS in vaccine treated patients and control patients	The primary objective is to compare the 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® as the control group.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of DFS and OS at 3, 5 and 10 years in vaccine and control groups, respectively; assessment of safety	The secondary objectives are to evaluate the 2 groups of subjects for: 5- and 10-year DFS; 3-year 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)	3 through 10 years

Collaborators and Investigators

• Sponsor: Galena Biopharma, Inc.
• Investigators: Principal Investigator: Elizabeth A Mittendorf, MD,FACS, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• Amin A, Benavides LC, Holmes JP, Gates JD, Carmichael MG, Hueman MT, Mittendorf EA, Storrer CE, Jama YH, Craig D, Stojadinovic A, Ponniah S, Peoples GE. Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer Immunol Immunother. 2008 Dec;57(12):1817-25. doi: 10.1007/s00262-008-0509-2. Epub 2008 Apr 8.
• Mittendorf EA, Clifton GT, Holmes JP, Clive KS, Patil R, Benavides LC, Gates JD, Sears AK, Stojadinovic A, Ponniah S, Peoples GE. Clinical trial results of the HER-2/neu (E75) vaccine to prevent breast cancer recurrence in high-risk patients: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer. 2012 May 15;118(10):2594-602. doi: 10.1002/cncr.26574. Epub 2011 Oct 11.
• Mittendorf EA, Lu B, Melisko M, Price Hiller J, Bondarenko I, Brunt AM, Sergii G, Petrakova K, Peoples GE. Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial. Clin Cancer Res. 2019 Jul 15;25(14):4248-4254. doi: 10.1158/1078-0432.CCR-18-2867. Epub 2019 Apr 29.

Helpful Links

• Sponsor website
• Vaccine site

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): September 21, 2016
• Study Completion (Actual): September 21, 2016

Study Registration Dates

• First Submitted: November 20, 2011
• First Submitted That Met QC Criteria: November 22, 2011
• First Posted (Estimate): November 24, 2011

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: breast cancer; HER2; low or intermediate; node-positive tumors
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Sargramostim; Molgramostim
• Other Study ID Numbers: NeuVax™ PH3-01, BB-IND 009187; 2011-005219-98 (EudraCT Number)