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

PHASE3CompletedINTERVENTIONAL
Enrollment

758

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

September 21, 2016

Study Completion Date

September 21, 2016

Conditions
Breast Cancer With Low to Intermediate HER2 Expression
Interventions
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).

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).

Trial Locations (197)

1303

Serdika, Sofia

1527

Tsaritsa Yoanna - ISUL, Sofia

3526

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

4002

Central Onco Hospital, Plovdiv

5000

Complex Oncology Center, Veliko Tarnovo, Veliko Tarnovo

7400

Kaposi Mor County Teaching Hospital, Center for Clinical Oncology, Kaposvár

9010

Sveta Marina, Varna

10021

Fountain Medical Group, New York

10117

Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum, Berlin

10469

Eastchester Cancer Care Center, The Bronx

11791

Comprehensive Pain Management, Syosset

14221

APWI, Williamsville

15232

University of Pittsburgh Medical Center (UPMC) Cancer Center, Pittsburgh

15905

Conemaugh Memorial Hospital-Memorial Medical Center, Johnstown

16101

J. Fred Stoner, MD, New Castle

17325

Gettysburg Cancer Center, Hillsdale

18091

Progressive Pain Solutions, Wind Gap

20817

Center of Cancer and Blood Disorders (VEEDA network), Bethesda

21029

Vinnytsia Regional Clinical Oncology Center, Vinnytsia

22031

Virginia Cancer Specialists, Fairfax

24105

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel

25011

Kirovohrad Regional Oncology Center, Department of Mammology, Kirovohrad

27157

Wake Forest Baptist Health, Winston-Salem

28177

Brustzentrum Klinikum Bremen-Mitte gGmbH, Bremen

30265

Cancer Treatment Centers of America, Newnan

30309

Interventional Spine and Pain Management, Atlanta

30607

Northeast Georgia Cancer Care, Athens

31096

Rambam Health Care Campus, Haifa

31201

Central Georgia Cancer Care, Macon

32256

Cancer Specialists of North Florida (ICON), Jacksonville

32806

MD Anderson Center-Orlando Health, Orlando

33180

Innovative Medical Research of South Florida, Inc., Aventura

33308

Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center, Fort Lauderdale

33317

Florida Cancer Research Institute (Florida Cancer Care), Plantation

33324

Florida Cancer Care, Plantation

33612

H.Lee Moffitt Cancer Center and Research Institute, Tampa

35022

Alabama Oncology, Bessemer

35043

Universität Marburg, Marburg

36606

Physicians Pain Specialists of Alabama, P.C., Mobile

36607

Upper East Side Pain Medicine, P.C., New York

38120

The West Clinic, Memphis

38138

The West Clinic Comprehensive Breast Center, Germantown

40202

James Graham Brown Cancer Center, University of Louisville, Louisville

44302

Akron General Medical Center, Akron

44805

Institut de Cancérologie de l'Ouest/René Gauducheau, Saint Herblain, Nantes Cedex

48071

William Beaumont Hospital Cancer Center, Royal Oak

48080

Advanced Physical Medicine, Saint Clair Shores

48149

Universitätsklinikum Münster, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Münster

48183

Michigan Interventional Pain Center, Brownstown

48604

Glenn Saperstein, D.O., LLC, Saginaw

48796

Physiatry Consultants, Bay City

49100

Rabin Medical Centre, Petah Tikva

49102

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

49933

Institut de Cancérologie de l'Ouest Siet Paul Papin, Angers

50000

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

52336

Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center, Milwaukee

52621

Sheba Medical Centre, Tel Hasomer

54290

Klinikum Mutterhaus der Borromaeerinnen, Trier

58013

Chernivtsi Regional Clinical Oncology Center, Day Care Unit, Chernivtsi

58501

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

59020

Centre Oscar Lambret, Cédex

60590

Universitätsklinikum Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe, Frankfurt

60611

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

61024

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

61070

Kharkiv Regional Clinical Oncology Center, Day Care Unit, Kharkiv

65000

Odesa Regional Clinical Hospital, Center for Mastology, Odesa

66210

Pain Management Institute, Overland Park

67214

Cancer Center of Kansas, Wichita

69040

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

69120

Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie, Heidelberg

70374

Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik, Stuttgart

70809

Mary Bird Perkins Cancer Center, Baton Rouge

74133

Cancer Treatment Centers of America, Tulsa

75235

PRIDE, Dallas

75390

UT Southwestern Medical Center / Simmons Comprehensive Cancer Center, Dallas

76100

Kaplan Medical Centre, Rehovot

77030

Baylor College of Medicine, Houston

The University of Texas MD Anderson Cancer Center, Houston

University of Texas MD Anderson Cancer Center, Houston

78229

Cancer Care Centers of South Texas, San Antonio

Clinical Trials of Texas, Inc, San Antonio

78234

Brooke Army Medical Center (now SAMMC), Fort Sam Houston

79031

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

80045

University of Colorado Cancer Center, Anschutz Medical Campus, Aurora

80401

Red Rocks Center for Rehabilitation, Golden

80637

Rotkreuzklinikum München gGmbH, Frauenklinik, München

83087

Donetsk City Oncology Center, Donetsk

83092

Donetsk Regional Antitumor Center, Oncosurgery Department #2, Donetsk

83582

Pain Centers Nationwide, Peoria

85254

Valley Pain Consultants, Scottsdale

87500

Mariupol City Interdistrict Oncology Center, Surgery Department #2, Mariupol

88014

Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy, Uzhhorod

90033

University of Southern California/Norris Cancer Hospital, Los Angeles

90035

Alexander Ford, MD, Los Angeles

90036

Cancer Care Institute, Los Angeles

Pete J. Ruane, MD, Inc., Los Angeles

90048

Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute, Los Angeles

90404

Pain Institute of Santa Monica, Santa Monica

91367

Randy Scharlach, MD, Woodland Hills

91505

East Valley Hematology and Oncology Medical Group, Burbank

92009

Coastal Pain Research, Carlsbad

92020

Navajo Road Pain Management Center, El Cajon

92093

Moores UC San Diego Cancer Center (UCSD), San Diego

92618

Interventional Pain Management, Irvine

92653

South Orange County Surgical Medical Group, Laguna Hills

92801

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

93720

California Cancer Associates for Research and Excellence, Inc., Fresno

California Cancer Associates For Research and Excellence, Fresno

94115

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

95000

Clinical Diagnostics Center, Simferopol

97239

OHSU Knight Cancer Institute, Portland

98104

Swedish Cancer Institute Research, Seattle

98405

Multicare Health System-Research Institute, Tacoma

100665

Weill Cornell Medical College, New York

115478

N.N. Blokhin Russian Cancer Research Center, Moscow

N.N. Blokhin Russian Cancer Reserach Center, Moscow

150054

Yaroslavl Regional Oncology Center, Yaroslavl

153040

Ivanovo Regional Oncology Center, Ivanovo

163045

Arkhangelsk Clinical Oncology Center, Arkhangelsk

173016

Regional Clinical Oncology Center, Veliky Novgorod

191104

Leningrad Regional Oncology Center, Saint Petersburg

194017

St. Petersburg Clinical Hospital, Saint Petersburg

195067

Mechnikov North-Western State Medical University, Saint Petersburg

197758

Petrov Research Institute of Oncology, Saint Petersburg

198255

Municipal Clinical Oncology Center, Saint Petersburg

200347

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

300239

Oncomed SRL, Department of Medical Oncology, Timișoara

302020

Orel Oncology Center, Oryol

305035

Kursk Regional Clinical Oncology Center, Kursk

350040

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

354057

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

357502

Pyatigorsk Oncology Center, Pyatigorsk

390011

Medical Institution of Ryazan Region, Ryazan

392013

Tambov Regional Clinical Oncology Center, Tambov

400015

"Prof. Dr. Ion Chiricuta Institute of Oncology", Cluj-Napoca

400058

Medisprof SRL, Department of Medical Oncology, Cluj-Napoca

404130

Volgograd Regional Oncology Center #3, Volzhskiy

410469

"Gavril Curteanu Municipal Clinical Hospital", Oradea

420029

Republican Clinical Oncoogy Center, Kazan'

430031

Dr. Constantin Opris County Emergency Hospital, Department of Oncology, Baia Mare, Maramures

430032

Republican Oncology Center, Saransk

443031

Samara Regional Clinical Oncology Center, Samara

450000

Bashkir State Medical University, Ufa

460051

Orenburg Regional Clinical Oncology Center, Orenburg

603006

Clinical Diagnostics Center, Nizhny Novgorod

603081

Nizhny Novgorod Regional Oncology Center, Nizhny Novgorod

620036

Sverdlovsk Regional Oncology Center, Yekaterinburg

634028

Research Institute of Oncology, Tomsk

660133

Krasnoyarsk Kryzhanovsky Regional Oncology Center, Krasnoyarsk

664035

Regional Oncology Center, Irkutsk

700483

Iasi Regional Oncology Institute, Department of Medical Oncology, Iași

06810

Western Connecticut Health Network, Danbury Hospital, Danbury

06904

Stamford Hospital, Bennett Cancer Center, Stamford

06905

Pain Management Associates of CT, PC, Stamford

02215

Beth Israel Deaconess Medical Center, Boston

01805

Lahey Clinic Department of Hematology and Oncology, Burlington

02904

Jerrold Rosenberg, MD, Providence

T6G1Z2

Cross Cancer Institute, Edmonton

P3E 5J1

Health Sciences North Cancer Centre, Greater Sudbury

K1H 8L6

Ottawa Hospital Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Research Institute, Toronto

J4V 2H1

Hospital Charles LeMorne, Greenfield Park

656 53

Masaryk Memorial Cancer Institute, Comprehensive Cancer Care Clinic, Brno

500 05

University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy, Hradec Králové

775 20

University Hospital Olomouc, Clinic of Oncology, Olomouc

128 08

General University Hospital in Prague, Clinic of Oncology, Prague

06189

Centre Antoine Lacassagne, Nice

D-91054

Universitätsklinikum Erlangen, Frauenklinik, Erlangen

D-45136

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

D-97080

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

H-5000

Hetenyi Geza Hospital, Department of Oncology, Szolnok

H-1032

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

H-1083

Semmelweis University, Department of Diagnostic Radiology and Oncotherapy, Budapest

H-9024

Petz Aladar County Teaching Hospital, Center for Oncoradiology, Győr

51-124

Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy, Kamienskiego

81-519

Polish Red Cross Marine Hospital, Department of Chemotherapy, Gdynia

93-513

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

61-866

Greater Poland Cancer Center, Department of Chemotherapy, Poznan

04-125

Magodent, Warsaw

Non-Public Health Care Facility MAGODENT, Warsaw

011171

Filantropia Clinical Hospital, Obstetrics and Gynaecology Department, Bucharest

030171

Coltea Clinical Hospital, Oncology Department, Bucharest

050098

Bucharest Universtiy Emergency Hosptial, Oncology Department, Bucharest

04107

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

03115

Kyiv City Clinical Oncology Center, Department of Chemotherapy, Kyiv

SK10 3BL

Macclesfield District General Hospital, Macclesfield

M20 4BX

The Christie NHS Foundation Trust, Withington

TS4 3BW

James Cook University Hospital, Middlesbrough

PL6 8DH

Plymouth Oncology Centre, Derriford Hospital, Plymouth

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

LS9 7TF

Leeds Teaching Hospitals Trust, St. James University Hospital, Leeds

LE1 5WW

Leicester Royal Infirmary, Leicester

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

NG7 2UH

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

S10 2SJ

Weston Park Hospital, Sheffield

SO16 6YD

Southampton General Hospital, Southampton

ST4 6QG

University Hospital of North Staffordshire, Stoke-on-Trent

Sponsors
All Listed Sponsors
lead

Galena Biopharma, Inc.

INDUSTRY