AzTrials
AzTrials

Breast Cancer With Low to Intermediate HER2 ExpressionPhase 3PRESENTNCT01479244

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

A Phase 3 study testing NeuVax™ vaccine and Leukine® (sargramostim, GM-CSF) and water for injection in people with Breast Cancer With Low to Intermediate HER2 Expression, run by Galena Biopharma, Inc. at 197 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
NeuVax™ vaccine and Leukine® (sargramostim, GM-CSF) and water for injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
758 participants
Where
197 sitesin 13 countries
Study dates
Nov 2011to 21 Sep 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Total mastectomy-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II
  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

197 sites in 13 countries.

197 sites in 13 countries

United States81 sites

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Northeast Georgia Cancer Care

    Athens, Georgia, 30607

  • Interventional Spine and Pain Management

    Atlanta, Georgia, 30309

  • University of Colorado Cancer Center, Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Innovative Medical Research of South Florida, Inc.

    Aventura, Florida, 33180

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Physiatry Consultants

    Bay City, Michigan, 48796

  • Alabama Oncology

    Bessemer, Alabama, 35022

  • Center of Cancer and Blood Disorders (VEEDA network)

    Bethesda, Maryland, 20817

  • St. Alexius Medical Center, Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Michigan Interventional Pain Center

    Brownstown, Michigan, 48183

  • East Valley Hematology and Oncology Medical Group

    Burbank, California, 91505

  • Lahey Clinic Department of Hematology and Oncology

    Burlington, Massachusetts, 01805

  • Coastal Pain Research

    Carlsbad, California, 92009

  • Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center

    Chicago, Illinois, 60611

  • PRIDE

    Dallas, Texas, 75235

  • UT Southwestern Medical Center / Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390

  • Western Connecticut Health Network, Danbury Hospital

    Danbury, Connecticut, 06810

  • Navajo Road Pain Management Center

    El Cajon, California, 92020

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center

    Fort Lauderdale, Florida, 33308

  • Brooke Army Medical Center (now SAMMC)

    Fort Sam Houston, Texas, 78234

  • California Cancer Associates for Research and Excellence, Inc.

    Fresno, California, 93720

  • California Cancer Associates For Research and Excellence

    Fresno, California, 93720

  • St. Jude Medical Center, Virginia K. Crosson Cancer Center

    Fullerton, California, 92801

  • The West Clinic Comprehensive Breast Center

    Germantown, Tennessee, 38138

  • Red Rocks Center for Rehabilitation

    Golden, Colorado, 80401

  • Gettysburg Cancer Center

    Hillsdale, Pennsylvania, 17325

  • Baylor College of Medicine

    Houston, Texas, 77030

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Interventional Pain Management

    Irvine, California, 92618

  • Cancer Specialists of North Florida (ICON)

    Jacksonville, Florida, 32256

  • Conemaugh Memorial Hospital-Memorial Medical Center

    Johnstown, Pennsylvania, 15905

  • South Orange County Surgical Medical Group

    Laguna Hills, California, 92653

  • University of Southern California/Norris Cancer Hospital

    Los Angeles, California, 90033

  • Alexander Ford, MD

    Los Angeles, California, 90035

  • Cancer Care Institute

    Los Angeles, California, 90036

  • Pete J. Ruane, MD, Inc.

    Los Angeles, California, 90036

  • Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048

  • James Graham Brown Cancer Center, University of Louisville

    Louisville, Kentucky, 40202

  • Central Georgia Cancer Care

    Macon, Georgia, 31201

  • The West Clinic

    Memphis, Tennessee, 38120

  • Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center

    Milwaukee, Wisconsin, 52336

  • Physicians Pain Specialists of Alabama, P.C.

    Mobile, Alabama, 36606

  • J. Fred Stoner, MD

    New Castle, Pennsylvania, 16101

  • Fountain Medical Group

    New York, New York, 10021

  • Weill Cornell Medical College

    New York, New York, 100665

  • Upper East Side Pain Medicine, P.C.

    New York, New York, 36607

  • Cancer Treatment Centers of America

    Newnan, Georgia, 30265

  • MD Anderson Center-Orlando Health

    Orlando, Florida, 32806

  • Pain Management Institute

    Overland Park, Kansas, 66210

  • Pain Centers Nationwide

    Peoria, Arizona, 83582

  • University of Pittsburgh Medical Center (UPMC) Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Florida Cancer Research Institute (Florida Cancer Care)

    Plantation, Florida, 33317

  • Florida Cancer Care

    Plantation, Florida, 33324

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

  • Jerrold Rosenberg, MD

    Providence, Rhode Island, 02904

  • William Beaumont Hospital Cancer Center

    Royal Oak, Michigan, 48071

  • Glenn Saperstein, D.O., LLC

    Saginaw, Michigan, 48604

  • Advanced Physical Medicine

    Saint Clair Shores, Michigan, 48080

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78229

  • Clinical Trials of Texas, Inc

    San Antonio, Texas, 78229

  • Moores UC San Diego Cancer Center (UCSD)

    San Diego, California, 92093

  • University of California, San Francisco (UCSF), Hellen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Pain Institute of Santa Monica

    Santa Monica, California, 90404

  • Valley Pain Consultants

    Scottsdale, Arizona, 85254

  • Swedish Cancer Institute Research

    Seattle, Washington, 98104

  • Stamford Hospital, Bennett Cancer Center

    Stamford, Connecticut, 06904

  • Pain Management Associates of CT, PC

    Stamford, Connecticut, 06905

  • Comprehensive Pain Management

    Syosset, New York, 11791

  • Multicare Health System-Research Institute

    Tacoma, Washington, 98405

  • H.Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Eastchester Cancer Care Center

    The Bronx, New York, 10469

  • Cancer Treatment Centers of America

    Tulsa, Oklahoma, 74133

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • APWI

    Williamsville, New York, 14221

  • Progressive Pain Solutions

    Wind Gap, Pennsylvania, 18091

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • Randy Scharlach, MD

    Woodland Hills, California, 91367

Other trials in United States

Russia30 sites

  • Arkhangelsk Clinical Oncology Center

    Arkhangelsk, 163045

  • Regional Oncology Center

    Irkutsk, 664035

  • Ivanovo Regional Oncology Center

    Ivanovo, 153040

  • Republican Clinical Oncoogy Center

    Kazan', Tatarstan Republic, 420029

  • Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration

    Krasnodar, 350040

  • Krasnoyarsk Kryzhanovsky Regional Oncology Center

    Krasnoyarsk, 660133

  • Kursk Regional Clinical Oncology Center

    Kursk, 305035

  • N.N. Blokhin Russian Cancer Research Center

    Moscow, 115478

  • N.N. Blokhin Russian Cancer Reserach Center

    Moscow, 115478

  • Clinical Diagnostics Center

    Nizhny Novgorod, 603006

  • Nizhny Novgorod Regional Oncology Center

    Nizhny Novgorod, 603081

  • Orenburg Regional Clinical Oncology Center

    Orenburg, 460051

  • Orel Oncology Center

    Oryol, 302020

  • Pyatigorsk Oncology Center

    Pyatigorsk, Stavropol Kray, 357502

  • Medical Institution of Ryazan Region

    Ryazan, 390011

  • Leningrad Regional Oncology Center

    Saint Petersburg, 191104

  • St. Petersburg Clinical Hospital

    Saint Petersburg, 194017

  • Mechnikov North-Western State Medical University

    Saint Petersburg, 195067

  • Petrov Research Institute of Oncology

    Saint Petersburg, 197758

  • Municipal Clinical Oncology Center

    Saint Petersburg, 198255

  • Samara Regional Clinical Oncology Center

    Samara, 443031

  • Republican Oncology Center

    Saransk, Respublika Mordoviya, 430032

  • Oncology Center #2, Department of Healthcare of Krasnodar Territory Administration

    Sochi, Krasnodarskiy Kray, 354057

  • Tambov Regional Clinical Oncology Center

    Tambov, 392013

  • Research Institute of Oncology

    Tomsk, 634028

  • Bashkir State Medical University

    Ufa, 450000

  • Regional Clinical Oncology Center

    Velikiy Novgorod, 173016

  • Volgograd Regional Oncology Center #3

    Volzhskiy, 404130

  • Yaroslavl Regional Oncology Center

    Yaroslavl, 150054

  • Sverdlovsk Regional Oncology Center

    Yekaterinburg, 620036

Other trials in Russia

Ukraine17 sites

  • Chernivtsi Regional Clinical Oncology Center, Day Care Unit

    Chernivtsi, 58013

  • Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy

    Dnipropetrovsk, 49102

  • Donetsk City Oncology Center

    Donetsk, 83087

  • Donetsk Regional Antitumor Center, Oncosurgery Department #2

    Donetsk, 83092

  • Kharkiv Regional Clinical Oncology Center, Day Care Unit

    Kharkiv, Kyivskyi District, 61070

  • State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine

    Kharkiv, 61024

  • Public Institution: Kiev Regional Oncology Hospital within Kyiv Regional Council

    Kiev, 04107

  • Kirovohrad Regional Oncology Center, Department of Mammology

    Kirovohrad, 25011

  • Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy

    Kryvyi Rih, Dnipropetrovsk Oblast, 50000

  • Kyiv City Clinical Oncology Center, Department of Chemotherapy

    Kyiv, 03115

  • Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy

    Lviv, 79031

  • Mariupol City Interdistrict Oncology Center, Surgery Department #2

    Mariupol, Donetsk Oblast, 87500

  • Odesa Regional Clinical Hospital, Center for Mastology

    Odesa, 65000

  • Clinical Diagnostics Center

    Simferopol, Autonomous Republic of Crimea, 95000

  • Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy

    Uzhhorod, 88014

  • Vinnytsia Regional Clinical Oncology Center

    Vinnytsia, 21029

  • Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council

    Zaporizhia, 69040

Other trials in Ukraine

Germany13 sites

  • Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum

    Berlin, 10117

  • Brustzentrum Klinikum Bremen-Mitte gGmbH

    Bremen, 28177

  • Universitätsklinikum Erlangen, Frauenklinik

    Erlangen, D-91054

  • Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Klinik für Senologie/Brustzentrum

    Essen, D-45136

  • Universitätsklinikum Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe

    Frankfurt, 60590

  • Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie

    Heidelberg, 69120

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Universität Marburg

    Marburg, 35043

  • Rotkreuzklinikum München gGmbH, Frauenklinik

    München, 80637

  • Universitätsklinikum Münster, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

    Münster, 48149

  • Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik

    Stuttgart, 70374

  • Klinikum Mutterhaus der Borromaeerinnen

    Trier, 54290

  • Gemeinschaftspraxis für Innere Medizin, Haematologie und internistische Onkologie Dr. R Schlag/Dr. Schoettker

    Würzburg, D-97080

Other trials in Germany

United Kingdom12 sites

  • Leeds Teaching Hospitals Trust, St. James University Hospital

    Leeds, West Yorkshire, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Macclesfield District General Hospital

    Macclesfield, Cheshire, SK10 3BL

  • James Cook University Hospital

    Middlesbrough, Middlesborough, TS4 3BW

  • Academic Unit of Oncology, Nottingham University Hospital-City Campus

    Nottingham, NG7 2UH

  • Plymouth Oncology Centre, Derriford Hospital

    Plymouth, Plymouth, PL6 8DH

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • Southampton General Hospital

    Southampton, SO16 6YD

  • University Hospital of North Staffordshire

    Stoke-on-Trent, ST4 6QG

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

  • The Christie NHS Foundation Trust

    Withington, Manchester, M20 4BX

Other trials in United Kingdom

Romania10 sites

  • Dr. Constantin Opris County Emergency Hospital, Department of Oncology

    Baia Mare, Maramures, 430031

  • Filantropia Clinical Hospital, Obstetrics and Gynaecology Department

    Bucharest, 011171

  • Coltea Clinical Hospital, Oncology Department

    Bucharest, 030171

  • Bucharest Universtiy Emergency Hosptial, Oncology Department

    Bucharest, 050098

  • Medisprof SRL, Department of Medical Oncology

    Cluj-Napoca, Cluj, 400058

  • "Prof. Dr. Ion Chiricuta" Institute of Oncology

    Cluj-Napoca, 400015

  • Oncology Center "Sf. Nectarie", Department of Medical Oncology

    Craiova, Dolj, 200347

  • Iasi Regional Oncology Institute, Department of Medical Oncology

    Iași, 700483

  • "Gavril Curteanu" Municipal Clinical Hospital

    Oradea, Bihor County, 410469

  • Oncomed SRL, Department of Medical Oncology

    Timișoara, 300239

Other trials in Romania

Hungary6 sites

  • Szent Margit Hospital, V. Department of Internal Medicine, Oncology

    Budapest, H-1032

  • Semmelweis University, Department of Diagnostic Radiology and Oncotherapy

    Budapest, H-1083

  • Petz Aladar County Teaching Hospital, Center for Oncoradiology

    Győr, H-9024

  • Kaposi Mor County Teaching Hospital, Center for Clinical Oncology

    Kaposvár, 7400

  • Borsod-Abauj-Zemplen County Hospital and University Educational Hospital, Center for Clinical Oncology and Radiology

    Miskolc, 3526

  • Hetenyi Geza Hospital, Department of Oncology

    Szolnok, Jász-Nagykun-Szolnok, H-5000

Other trials in Hungary

Poland6 sites

  • Polish Red Cross Marine Hospital, Department of Chemotherapy

    Gdynia, 81-519

  • Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy

    Kamienskiego, Wroclaw, 51-124

  • Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Chemotheraphy

    Lodz, 93-513

  • Greater Poland Cancer Center, Department of Chemotherapy

    Poznan, 61-866

  • Magodent

    Warsaw, 04-125

  • Non-Public Health Care Facility MAGODENT

    Warsaw, 04-125

Other trials in Poland

Bulgaria5 sites

  • Central Onco Hospital

    Plovdiv, 4002

  • Serdika

    Sofia, 1303

  • Tsaritsa Yoanna - ISUL

    Sofia, 1527

  • Sveta Marina

    Varna, 9010

  • Complex Oncology Center, Veliko Tarnovo

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Canada5 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G1Z2

  • Health Sciences North Cancer Centre

    Greater Sudbury, Ontario, P3E 5J1

  • Hospital Charles LeMorne

    Greenfield Park, Quebec, J4V 2H1

  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Czechia4 sites

  • Masaryk Memorial Cancer Institute, Comprehensive Cancer Care Clinic

    Brno, 656 53

  • University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy

    Hradec Králové, 500 05

  • University Hospital Olomouc, Clinic of Oncology

    Olomouc, 775 20

  • General University Hospital in Prague, Clinic of Oncology

    Prague, 128 08

Other trials in Czechia

France4 sites

  • Institut de Cancérologie de l'Ouest Siet Paul Papin

    Angers, Cedex 9, 49933

  • Centre Oscar Lambret

    Cédex, Lille, 59020

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut de Cancérologie de l'Ouest/René Gauducheau

    Saint Herblain, Nantes Cedex, Loire-Atlantique, 44805

Other trials in France

Israel4 sites

  • Rambam Health Care Campus

    Haifa, Haifa District, 31096

  • Rabin Medical Centre

    Petah Tikva, 49100

  • Kaplan Medical Centre

    Rehovot, 76100

  • Sheba Medical Centre

    Tel Hasomer, Ramat Gan, 52621

Other trials in Israel

About this study

Official title: 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.
Read the 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
  1. 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.

Being tested
NeuVax™ vaccine, Leukine® (sargramostim, GM-CSF) and water for injection
Keywords
HER2, low or intermediate, breast cancer, node-positive tumors
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeuVax™ vaccineBiological

    Also called E75 peptide acetate , WFI, sargramostim, GM-CSF

    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).

  • Leukine® (sargramostim, GM-CSF) and water for injectionBiological

    Also called Leukine®

    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).

Study groups in NCT01479244
Study groupRoleWhat they receive
NeuVax™ExperimentalNeuVax™ in WFI solution with Leukine®
Receives: Biological: NeuVax™ vaccine
Leukine®Active comparatorLeukine® with WFI
Receives: Biological: Leukine® (sargramostim, GM-CSF) and water for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 36 months

Secondary outcomes (1)

  1. 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)

    Measured: 3 through 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completion21 Sep 2016
  4. Study completion21 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
758 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01479244
Sponsor's protocol ID
NeuVax™ PH3-01, BB-IND 009187
Other IDs
2011-005219-98
Acronym
PRESENT
Status last verified
Feb 2017
First submitted
20 Nov 2011
Last updated
27 Feb 2017
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 18392824

  • 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.

    PubMed 21989902

  • 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.

    PubMed 31036542

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NeuVax™ vaccine and Leukine® (sargramostim, GM-CSF) and water for injection in people with Breast Cancer With Low to Intermediate HER2 Expression, run by Galena Biopharma, Inc. at 197 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in United States, Russia, Ukraine, Germany, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of DFS in vaccine treated patients and control patients (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01479244, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in