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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overPharmaceutical / IndustryNeuVax™ PH3-01, BB-IND 009187
2011-005219-98, NCT01479244

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Galena Biopharma

Elizabeth A Mittendorf, MD,FACSPrincipal Investigator

Gavin ChoyPh: 855-855-4253 Ext.113
  Email: gchoy@galenabiopharma.com

Trial Sites

U.S.A.
Alabama
  Bessemer
 Alabama Oncology
 Brittany White, BBA Ph: 205-939-7181
  Email: brittany.white@alabamaoncology.com
 Joanne Rossman, MDPrincipal Investigator
California
  Fullerton
 Virginia K. Crosson Cancer Center at St. Jude Medical Center
 Gail Torres Ph: 714-446-5642
  Email: MarieGail.Torres@stjoe.org
 William Lawler, MDPrincipal Investigator
  Laguna Hills
 South Orange County Surgical Medical Group
 Tracy Bessette Ph: 949-680-3490
  Email: tbessette@researchalliance.com
 Kenneth DeckPrincipal Investigator
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Suzanne Cabriales, MSN, OCN Ph: 310-248-6733
  Email: swains@cshs.org
 William Audeh, MDPrincipal Investigator
 USC/Norris Comprehensive Cancer Center and Hospital
 Zeno Ashai Ph: 323-865-0463
  Email: zeno.ashai@med.usc.edu
 Augustin Garcia, MDPrincipal Investigator
  San Diego
 Rebecca and John Moores UCSD Cancer Center
 Jillian McCarthy Ph: 858-822-4516
  Email: jmccarthy@ucsd.edu
 Richard Schwab, MDPrincipal Investigator
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Stephanie Ezrati Ph: 415-353-7857
  Email: EzratiS@cc.ucsf.edu
 Michelle Melisko, MDPrincipal Investigator
Colorado
  Aurora
 University of Colorado Anschutz Medical Campus
 Candice Gillmann Ph: 720-848-0660
  Email: candice.gillmann@ucdenver.edu
 Virginia F. BorgesPrincipal Investigator
Florida
  Fort Lauderdale
 Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center
 Lorrain Hickson Ph: 954-267-7750
  Email: lorraine.hickson@holy-cross.com
 Leonard Seigel, MDPrincipal Investigator
  Jacksonville
 Cancer Specialists of North Florida (ICON)
 Melissa Rammage, MS, RPh Ph: 904-519-2731
  Email: melissa.rammage@csnf.us
 Carol Starr Ph: 904-538-3667
  Email: carol.starr@csnf.us
 Suprith Badarinath, MDPrincipal Investigator
  Orlando
 M.D. Anderson Cancer Center at Orlando
 Monica Drouillard, RN Ph: 321-841-2285
  Email: monica.drouillard@orlandohealth.com
 Nikita Shah, MDPrincipal Investigator
  Plantation
 Florida Cancer Care
 Dina Hussein, RN, MSN Ph: 954-582-1850
  Email: dinah@flcancercare.com
 Elizabeth Tan-ChiuPrincipal Investigator
  Tampa
 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
 Katie Fick Ph: 813-745-8304
  Email: katie.fick@moffitt.org
 Hatem H. SolimanPrincipal Investigator
Georgia
  Athens
 Northeast Georgia Cancer Care, LLC - Medical Oncology
 Jamie Hodgson, CCRC Ph: 706-353-2990 Ext.279
  Email: jhodgson@negacancer.com
 Petrol Nikolinakos, MDPrincipal Investigator
  Macon
 Central Georgia Cancer Care, PC - Macon
 Joanne Kerr, RN Ph: 478-743-7068
  Email: jkerr@centralgacancercare.com
 Frederick M. SchnellPrincipal Investigator
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Jacqueline S. Jeruss, MD, PhD Ph: 312-503-4236
  Email: j-jeruss@northwestern.edu
 Jacqueline S. Jeruss, MD, PhDPrincipal Investigator
Kansas
  Wichita
 Cancer Center of Kansas, PA - Wichita
 Susan Stockton, RN,OCN Ph: 316-613-4318
  Email: susan.stockton@cancercenterofkansas.com
 Shaker R. DakhilPrincipal Investigator
Kentucky
  Louisville
 James Graham Brown Cancer Center at University of Louisville
 Belma Kantardzic Ph: 502-562-4356
  Email: bnkant01@louisville.edu
 Elizabeth Riley, MDPrincipal Investigator
Louisiana
  Baton Rouge
 Mary Bird Perkins Cancer Center - Baton Rouge
 Cynthia Knox, RN Ph: 225-215-1342
  Email: cknox@marybird.com
 Derrick W Spell, MDPrincipal Investigator
Maryland
  Bethesda
 Center of Cancer and Blood Disorders (VEEDA network)
 Julie Guiliani Ph: 301-571-2016 Ext.2103
  Email: jneff@ccbdmd.com
 Ralph Vincent BocciaPrincipal Investigator
Massachusetts
  Boston
 Beth Israel Deaconess Medical Center
 David Avigan, MD Ph: 617-667-9920
  Email: davigan@bidmc.harvard.edu
 David AviganPrincipal Investigator
  Burlington
 Lahey Clinic Medical Center - Burlington
 Kori Hesse Ph: 781-744-3071
  Email: kori.hesse@lahey.org
 Corrine ZarwanPrincipal Investigator
Michigan
  Royal Oak
 Beaumont Health System
 Lisa Sahadi Ph: 248-330-4213
  Email: Lisa.sahadi@beaumont.edu
 Laura Nadeau, MDPrincipal Investigator
New York
  Bronx
 Eastchester Cancer Care Center
 Karen Hoffman, MD Ph: 718-732-4029
  Email: karen@eastchestercenter.com
 Anthony Hoffman, MDPrincipal Investigator
  New York
 New York Weill Cornell Cancer Center at Cornell University
 Ellen Chuang, MD Ph: 212-821-0644
  Email: elc2007@med.cornell.edu
 Ellen Chuang, MDPrincipal Investigator
North Dakota
  Bismarck
 St. Alexius Medical Center Cancer Center
 Julie Wetzstein, CCRC Ph: 701-530-6960
  Email: jwetzstein@primecare.org
 Jayaram Bharadwaj, MDPrincipal Investigator
Oregon
  Portland
 Knight Cancer Institute at Oregon Health and Science University
 Knight Clinical Trials Line Ph: 503-494-1080
  Email: trials@ohsu.edu
 Steve Chui, MDPrincipal Investigator
Pennsylvania
  Johnstown
 Conemaugh Memorial Hospital-Memorial Medical Center
 Gerard Garguilo, MD Ph: 814-539-6797
  Email: ggargui@conemaugh.org
 Gerard Garguilo, MDPrincipal Investigator
  Pittsburgh
 University of Pittsburgh Medical Center (UPMC) Cancer Center
 Brenda Steele Ph: 412-641-2261
  Email: steebx@upmc.edu
 Adam Brufsky, FACP, MD,PhDPrincipal Investigator
Tennessee
  Memphis
 West Clinic - East Memphis
 Kelly Woodard, MS Ph: 901-260-9288
  Email: kwoodard@theacornnetwork.com
 Lee S. SchwartzbergPrincipal Investigator
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Damaris Dotson Ph: 214-648-4981
  Email: damaris.dotson@utsouthwestern.edu
 Barbara Haley, MDPrincipal Investigator
  Ft. Sam Houston
 Brooke Army Medical Center (now SAMMC)
 Karen L Arrington, BSN, RN, CCRP Ph: 210-243-5711
  Email: karen@cancerincite.com
 Nathan M. Shumway, MD, FACPPrincipal Investigator
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Sara E Stassen Ph: 713-563-1681
  Email: SEStassen@mdanderson.org
 Elizabeth A Mittendorf, MD, FACPPrincipal Investigator
Virginia
  Fairfax
 Virginia Cancer Specialists
 Nighisti Tewelde Ph: 703-894-3810
  Email: Nighisti.Tewelde@usoncology.com
 Nicholas Robert, MDPrincipal Investigator
Washington
  Seattle
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Sarah Fanizzi Ph: 206-386-2444
  Email: sarah.fanizzi@swedish.org
 Henry Kaplan, MD Ph: 206-215-3086
  Email: SwedishCancerResearch@swedish.org
 Henry Kaplan, MDPrincipal Investigator
  Tacoma
 Multicare Health System-Research Institute
 Christine Goetz Ph: 253-403-7193
  Email: christine.goetz@multicare.org
 Yoshio Inoue, MDPrincipal Investigator
Wisconsin
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Tina WF Yen, MD, MS Ph: 414-805-5495
  Email: tyen@mcw.edu
 Tina W Yen, MD, MSPrincipal Investigator
Canada
Alberta
  Edmonton
 Cross Cancer Institute at University of Alberta
 Noor Khattak Ph: 780 577 8072
  Email: noor.khattak@albertahealthservices.ca
 John P Mackey, MDPrincipal Investigator
Ontario
  Ottawa
 Ottawa Hospital Regional Cancer Centre - General Campus
 Diane Robbins Ph: 613-737-7700 Ext.70302
  Email: drobbins@toh.on.ca
 Roanne J Segal, MDPrincipal Investigator
  Sudbury
 Health Sciences North Cancer Centre
 Janet Dakins Ph: 705 522 6237 Ext.2532
  Email: jdakins@hsnsudbury.ca
 Scott Young, MDPrincipal Investigator
  Toronto
 Odette Cancer Centre at Sunnybrook
 Carolyn Lim Ph: 416 480 5000 Ext.7219
  Email: carolyn.lim@sunnybrook.ca
 Kathleen I. PritchardPrincipal Investigator
Quebec
  Greenfield Park
 Hospital Charles LeMorne
 Veronique Machabee Ph: 450 466 5000 Ext.3226
  Email: veronique.machabee@rrsss16.gouv.qc.ca
 Catherine Prady, MDPrincipal Investigator
Czech Republic
  Brno
 Masaryk Memorial Cancer Institute, Cancer Care Clinic
 Renata Horova, DVM Ph: 420 543 136 226
  Email: renata.horova@mou.cz
 Katarina Petrakova, MD, PhDPrincipal Investigator
  Hradec Kralove
 University Hospital Hdradec Kralove, Clinical of Oncology and Radiotherapy
 Simona Sediva Ph: 420 495 832 489
  Email: simona.sediva@fnhk.cz
 Eugen Kubala, MDPrincipal Investigator
  Olomouc
 University Hospital Olomouc, Clinic of Oncology
 Magda Simkova Ph: 420 588 442 522
  Email: magda.simkova@fnol.cz
 Bohuslav Melichar, MDPrincipal Investigator
  Prague 2
 General University Hospital in Prague, Clinic of Oncology
 Marian Kavalec Ph: 420 224 966 405
  Email: marian.kavalec@vfn.cz
 Petra Tesarova, Assoc. Prof. MD, PhDPrincipal Investigator
France
  Angers
 Institut de Cancérologie de l'Ouest Siet Paul Papin
 Simon Dupuis Ph: +33 2 44 85 37 57
  Email: simon.dupuis@ico.unicancer.fr
 Sophie Abadie-Lacourtoisie, MDPrincipal Investigator
  Cédex
 Centre Oscar Lambret
 Stephanie Clisant Ph: +33 3 2029 5935
  Email: s-clisant@o-lambret.fr
 Géraldine Lauridant, MDPrincipal Investigator
  St Herblain, Nantes Cedex
 Institut de Cancérologie de l'Ouest/René Gauducheau
 Gwenaelle Lewandowski Ph: +33 2 4067 9748
  Email: gwenaelle.lewandowski@ico.unicancer.fr
 Mario Campone, MDPrincipal Investigator
Germany
  Berlin
 Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum
 Joerg Spahrbier Ph: +49 30 450664297
  Email: joerg.spahrbier@charite.de
 Nikola Bangemann, MDPrincipal Investigator
  Bremen
 Brustzentrum Klinikum Bremen-Mitte gGmbH
 Halil Merdivan Ph: +49 421 497 5361
  Email: halil.merdivan@klinikum-bremen-mitte.de
 Mustafa Aydogdu, Dr.Principal Investigator
  Erlangen
 Universitaet Erlangen
 Paul Gass, Dr. Ph: +49 9131 853 3553
  Email: fk-studienzentrale@uk-erlangen.de
 Claudia Rauh, MDPrincipal Investigator
  Essen
 Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Klinik für Senologie/Brustzentrum
 Dorothea Schindowski Ph: +49 201 174 33005
  Email: d.schindowski@kliniken-essen-mitte.de
 Juliane Lubitz
  Email: j.lubitz@kliniken-essen-mitte.de
 Scherko Kuemmel, MDPrincipal Investigator
  Frankfurt
 Klinikum der J.W. Goethe Universitaet
 Stefan Loitsch, Dr Ph: +49 69 6301 6850
  Email: stefanmarcel.loitsch@kgu.de
 Benjamin SchnappaufPrincipal Investigator
  Heidelberg
 Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie
 Monika Fischer Ph: +49 6221-567884
  Email: monika.fischer@med.uni-heidelberg.de
 Frederik Marmé, MDPrincipal Investigator
  Kiel
 University Hospital Schleswig-Holstein - Kiel Campus
 Kirsten Keller Ph: +49 431 597 2084
  Email: sgo@email.uni-kiel.de
 Christoph Mundhenke, MDPrincipal Investigator
  Marburg
 Universität Marburg
 Klaus Baumann, M.D. Ph: +49 6421 5866491
  Email: baumannk@med.uni-marburg.de
 Klaus Baumann, Dr.Principal Investigator
  Muenchen
 Rotkreuzklinikum München gGmbH, Frauenklinik
 Harry Reisch Ph: +49 89 15706 661
  Email: harry.reisch@swmbrk.de
 Claus A Hanusch, MDPrincipal Investigator
  Münster
 Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
 Ricarda Haier Ph: +49 251 83 44100
  Email: Ricarda.Haier@ukmuenster.de
 Joke Tio, MDPrincipal Investigator
  Stuttgart
 Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik
 Miriam Alisch Ph: +49 711 278 - 51852
  Email: m.alisch@klinikum-stuttgart.de
 Ulrich Karck, Prof. Dr.Principal Investigator
  Trier
 Krankenanstalt Mutterhaus der Borromaerinnen
 A.R. Waladkhani, Dr. Ph: +49 651 947 2795
  Email: waladkhani@mutterhaus.de
 Michael Clemens, Prof. MDPrincipal Investigator
  Wuerzburg
 Gemeinschaftspraxis für Innere Medizin, Haematologie und internistische Onkologie Dr. R Schlag/Dr. Schoettker
 Ursula Reichert Ph: +49 931 322 67108
  Email: u.reichert@schlag-onkologie.de
 Rudolf Schlag, MDSub-Investigator
 Bjoern Schoettker, MDPrincipal Investigator
Hungary
  Budapest
 Semmelweis University, Department of Diagnostic Radiology and Oncotherapy
 Andrea Makra Ph: 36 1 459 1500 Ext.51730
  Email: trial.sote@gmail.com
 Magdolna Dank, MDPrincipal Investigator
 Szent Margit Hospital, V. Department of Internal Medicine, Oncology
 Zsuzsanna Toth Ph: 36 1 250 2420
  Email: zsuzsanna.toth@coordination.hu
 Katalin Boer, MDPrincipal Investigator
  Gyor
 Petz Aladar County Teaching Hospital, Center for Oncoradiology
 Marta Janoki Ph: 36 96 507 972
  Email: janoki.m@gmail.com
 Tamas Pinter, MDPrincipal Investigator
  Kaposvar
 Kaposi Mor County Teaching Hospital, Center for Clinical Oncology
 Krisztina Decsi Ph: 36 82 501 300
  Email: decsikriszta@gmail.com
 Zoltan Vogyi, MDPrincipal Investigator
  Miskolc
 Borsod-Abauj-Zemplen County Hospital and University Educational Hospital, Center for Clinical Oncology and Radiology
 Katalin Molnar, MD Ph: 36 46 515 200
  Email: moka.onkorad@bazmkorhaz.hu
 Katalin Molnar, MDPrincipal Investigator
  Szolnok
 Hetenyi Geza Hospital, Department of Oncology
 Kata Nora Papp Ph: 36 56 503 603 Ext.3321
  Email: papp.kata.nora@gmail.com
 Tibor Csoszi, MDPrincipal Investigator
Israel
  Haifa
 Rambam Medical Center
 Anna Isakovitch Ph: +972 4 854 1258
  Email: a_isakovitch@rambam.health.gov.il
 Karen Drumea, MDPrincipal Investigator
  Petach Tikva
 Rabin Medical Center - Beilinson Campus
 Gal Medalia Ph: +972 2 9378076
  Email: galmed@clalit.org.il
 Solomon Stemmer, MDPrincipal Investigator
  Rehovot
 Kaplan Medical Centre
 Yael Shaked Ph: +972 8 9441006
  Email: yaelsha@clalit.org.il
 Noa Efrat, MDPrincipal Investigator
  Tel Hasomer
 Sheba Medical Centre
 Yula Hadzaev Ph: +972 3 3 5307035
  Email: yula.hadzaev@sheba.health.gov.il
 Shani Paluch-Shimon, MD.Principal Investigator
Poland
  Gdynia
 Polish Red Cross Marine Hospital, Department of Chemotherapy
 Krzysztof Lesniewki-Kmak Ph: 48 58 69 98 102
  Email: klkmak@szpital-morski.pl
 Krzysztof Lesniewki-Kmak, MDPrincipal Investigator
  Kamienskiego
 Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy
 Barbara Ziolkowska Ph: 48 71 32 70 453
  Email: barbara.ziolkowska@gazeta.pl
 Beata Freier, MDPrincipal Investigator
  Lodz
 Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Chemotheraphy
 Ewa Kalinka-Warzocha, MD, PhD Ph: 48 42 689 5477
  Email: ewakalinska@wp.pl
 Ewa Kalinka-Warzocha, MD, PhDPrincipal Investigator
 Nicolaus Copernicus Provincial Specialist Hospital In Lodz, Department of Chemotherapy
 Ewa Kalinka-Warzocha, M.D. Ph.D. Ph: 48 42 689 54 77
  Email: ewakalinka@wp.pl
 Ewa Kalinka-Warzocha, MD, PhDPrincipal Investigator
  Poznan
 Greater Poland Cancer Center, Department of Chemotherapy
 Lukasz Galus, MD Ph: 48 61 88 50 620
  Email: lukasz_galus@wp.pl
 Piotr Wysocki, MD, PhDPrincipal Investigator
  Warsaw
 Magodent
 Tomasz Sarosiek Ph: 48 (22) 430 8910
  Email: tomasz.sarosiek@magodent.com.pl
 Tomasz Sarosiek, MDPrincipal Investigator
 Non-Public Health Care Facility MAGODENT
 Tomasz Sarosiek, M.D. Ph.D. Ph: 00 48 22 430 89 20
  Email: tomasz.sarosiek@magodent.com.pl
 Tomasz Sarosiek, MD, PhDPrincipal Investigator
Republic of Bulgaria
  Plovdiv
 Central Onco Hospital
 Olga Mateva Ph: 359 32 990 007
  Email: coh.mateva@gmail.com
 Velko T Minchev, MDPrincipal Investigator
  Sofia
 Serdika
 Nelly Tashkova Ph: 359 887 793 8418
  Email: nelly.tashkova@gmail.com
 Constanta Timcheva, MD, PhDPrincipal Investigator
  Tarnovo
 Complex Oncology Center, Veliko Tarnovo
 Miroslava Gancheva Ph: 359 62 620 249
  Email: onkovt@abv.bg
 Mariya Racheva, MDPrincipal Investigator
  Varna
 Sveta Marina
 Assia Konsoulova, MD Ph: 359 52 978 388
  Email: dr.konsoulova@gmail.com
 Dimitar Kalev, MD, PhDPrincipal Investigator
Romania
  Baia Mare, Maramures
 Dr. Constantin Opris County Emergency Hospital, Department of Oncology
 Filip Dumitru, MD Ph: 40 741 074 059
  Email: filipd@spitaljbm.ro
 Filip Dumitru, MDPrincipal Investigator
  Bucharest
 Bucharest Universtiy Emergency Hosptial, Oncology Department
 Dan Jinga, MD Ph: 40 722 927 377
  Email: danjinga2002@yahoo.com
 Dan C Jinga, MDPrincipal Investigator
 Coltea Clinical Hospital, Oncology Department
 Ciprian Aldea, MD Ph: 40 722 214 982
  Email: aldea.ciprian@yahoo.com
 Ciprian Aldea, MDPrincipal Investigator
 Filantropia Clinical Hospital, Obstetrics and Gynaecology Department
 Prof. Gheorghe Peltecu, MD, PhD Ph: 40 744 874 350
  Email: peltecu@dnt.ro
 Prof. Gheorghe Peltecu, MD, PhDPrincipal Investigator
  Cluj-Napoca
 "Prof. Dr. Ion Chiricuta" Institute of Oncology
 Alexandru Eniu, MD Ph: 40 744 523 853
  Email: aleniu@iocn.ro
 Alexandru Eniu, MDPrincipal Investigator
 Medisprof SRL, Department of Medical Oncology
 Adrian Udrea, MD Ph: 40 751 274 636
  Email: adrianudrea@medisprof.ro
 Adrian Udrea, MDPrincipal Investigator
  Craiova
 Oncology Center "Sf. Nectarie", Department of Medical Oncology
 Michael Schenker, MD Ph: 40 722 161 545
  Email: mike_schenker@yahoo.com
 Michael Schenker, MDPrincipal Investigator
  Iasi
 Iasi Regional Oncology Institute, Department of Medical Oncology
 Assoc. Prof. Lucian Miron, Dr. Ph: 40 744 397 003
  Email: lucmir@gmail.com
 Assoc. Prof. Lucian Miron, MDPrincipal Investigator
  Oradea
 "Gavril Curteanu" Municipal Clinical Hospital
 Simona Mihutiu, MD Ph: 40 726 729 996
  Email: simonamihutiu@yahoo.com
 Simona Mihutiu, MDPrincipal Investigator
  Timisoara
 Oncomed SRL, Department of Medical Oncology
 Daniela Sirbu, MD Ph: 40 744 571 617
  Email: desirbu@yahoo.com
 Daniela Sirbu, MDPrincipal Investigator
Russia
  Arkhangelsk
 Arkhangelsk Clinical Oncology Center
 Natalia Lysova Ph: 007 8182 275913
  Email: chemother29@yandex.ru
 Liudmila Lebedeva, MDPrincipal Investigator
  Ekaterinburg
 Sverdlovsk Regional Oncology Center
 Irina Bulavina, MD Ph: 007 343 356 15 12
  Email: ibulavina@yandex.ru
 Irina Bulavina, MDPrincipal Investigator
  Irkutsk
 Irkutsk Regional Oncology Center
 Denis Yukalchuk, MD Ph: 007 3952 777 283 Ext.1062
  Email: yukalchukdyu@gmail.com
 Denis Yukalchuk, MDPrincipal Investigator
  Ivanovo
 Ivanovo Regional Oncology Center
 Natalya Polyakova, MD Ph: 007 4932 565 757
  Email: natalyapolyakova71@mail.ru
 Evgeny Gotovkin, MDPrincipal Investigator
  Kazan
 Republican Clinical Oncoogy Center
 Sufia Safina, MD, PhD Ph: 007 8435 257 340
  Email: ksafin@mail.ru
 Sufia Safina, MD, PhDPrincipal Investigator
  Krasnodar
 Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration
 Irina Davidenko, MD Ph: 007 8612 454 775
  Email: irina_dav@mail.ru
 Irina Davidenko, MDPrincipal Investigator
  Krasnoyarsk
 Krasnoyarsk Kryzhanovsky Regional Oncology Center
 Natalia Musaeva, MD Ph: 007 913 1893995
  Email: musa-eva100@mail.ru
 Prof. Yuri Dykhno, MD, PhD, DMedScPrincipal Investigator
  Kursk
 Kursk Regional Oncology Center
 Igor Lifirenko, MD Ph: 007 4712 52 95 53
  Email: pikood46@gmail.com
 Igor Kiselev, MDPrincipal Investigator
  Moscow
 N.N. Blokhin Russian Cancer Reserach Center
 Lidia Nelyubina, MD Ph: 007 495 324 6240
  Email: lydia.a.n@yandex.ru
 Lidia Nelyubina, MDPrincipal Investigator
 Russian Academy of Medical Sciences Cancer Research Center
 Maria Rodionova, MD Ph: 007 499 152 74 77
  Email: miss.rodionova@gmail.com
 Prof. Igor K Vorotnikov, MD, PhD, DMedSciPrincipal Investigator
  Nizhny Novgorod
 Clinical Diagnostics Center
 Prof. Anna Alyasova, MD, PhD, DMedSci Ph: 007 831 433 31 09
  Email: alyasovaav68@mail.ru
 Prof. Anna Alyasova, MD, PhD, DMedSciPrincipal Investigator
 Nizhny Novgorod Regional Oncology Center
 Olga Tyurina Ph: 007 8314 645398
  Email: lolo5252@mail.ru
 Marina Matrosova, MDPrincipal Investigator
  Orel
 Orel Oncological Center
 Alexander Pencheny, MD Ph: 007 4862 763 387
  Email: himio5@mail.ru
 Alexander Pencheny, MDPrincipal Investigator
  Orenburg
 Orenburg Regional Clinical Oncology Center
 Vadim Shirinkin, MD Ph: 007 3532 331 135
  Email: orenonco.shirinkinvb@rambler.ru
 Vadim Shirinkin, MDPrincipal Investigator
  Pyatigorsk
 Pyatigorsk Oncology Center
 Vladimir Vladimirov, MD, PhD Ph: 007 8793 973 362
  Email: vladvlad@megalog.ru
 Vladimir Vladimirov, MD, PhD, DMedSciPrincipal Investigator
  Ryazan
 Medical Institution of Ryazan Region
 Marina Shomova, MD Ph: 007 4912 270 514
  Email: doc_mvs@rambler.ru
 Marina Shomova, MDPrincipal Investigator
  Samara
 Samara Regional Clinical Oncology Center
 Anastasia Pankova Ph: 8 8469 947650
  Email: sokod70@mail.ru
 Prof. Mikhail Kopp, MD, PhD, DMedSciPrincipal Investigator
  Saransk
 Republican Oncology Center
 Pavel Skopin, MD Ph: 007 927 181 5631
  Email: skopinpi@mail.ru
 Pavel Skopin, MDPrincipal Investigator
  St Petersburg
 Petrov Research Institute of Oncology
 Olga Ivanova, MD Ph: 007 812 670 76 38
  Email: olalivanova@yandex.ru
 Olga Ivanova, MD, PhDPrincipal Investigator
  St. Petersburg
 Leningrad Regional Oncology Center
 Anna Vats Ph: 007 812 945 33 18
  Email: vatsanna@mail.ru
 Dmitriy Krasnozhon, MD, PhDPrincipal Investigator
 Mechnikov North-Western State Medical University
 Sevda Sadygova, MD Ph: 007 921 6360332
  Email: sevda78@yandex.ru
 Eldar Topuzov, MD, PhD, DMedSciPrincipal Investigator
 Municipal Clinical Oncology Center
 Lada Selezneva, MD Ph: 007 812 2346189
  Email: ladayana@mail.ru
 Alexey Manikhas, MDPrincipal Investigator
 St. Petersburg Clinical Hospital
 Anna Buiniakova, MD Ph: 007 812 293 9087
  Email: anna.bnk@mail.ru
 Anna Buiniakova, MDPrincipal Investigator
  Tambov
 Tambov Regional Clinical Oncology Center
 Anton Tischenko, MD Ph: 007 4752 725 351
  Email: avtischenko2@gmail.com
 Vladimir Milovanov, MDPrincipal Investigator
  Ufa
 Bashkir State Medical University
 Viktoria Kononova, MD Ph: 007 347 324 34 13
  Email: kochanova21@mail.ru
 Adel Izmailov, MDPrincipal Investigator
  Veliky
 Regional Clinical Oncology Center
 Vladimir Ivanchenko, MD Ph: 007 921 731 7047
  Email: mednovonko@mail.ru
 Vladimir Ivanchenko, MDPrincipal Investigator
  Volzhskiy
 Volgograd Regional Oncology Center #3
 Evgeny Rusanov Ph: 007 928 370 8244
  Email: rusanov.ek@yandex.ru
 Nadezhda Kovalenko, MD, PhDPrincipal Investigator
  Yaroslavl
 Regional Oncology Center - Yaroslavl
 Marina Shultishova Ph: 007 4852 721 044
  Email: mshultishova@rambler.ru
 Sergey Cheporov, MD, PhDPrincipal Investigator
Ukraine
  Chernivtsi
 Chernivtsi Regional Clinical Oncology Center, Day Care Unit
 Hontsa Iryna, MD Ph: 38 0372 547 650
  Email: iryna.hontsa@gmail.com
 Anatolii Oleksandrovych Hontsa, MDPrincipal Investigator
  Dnipropetrovsk
 Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy
 Yuliia Yarosh Ph: 38 0562 585 372
  Email: yarosh_yv@mail.ru
 Prof. Ihor Bondarenko, MD, PhD, DMedSciPrincipal Investigator
  Kharkiv
 Kharkiv Regional Clinical Oncology Center, Day Care Unit
 Natalia Krizhanivska Ph: 38 057 311 80 36
  Email: natali.krz@gmail.com
 Yurii Vinnyk, MDPrincipal Investigator
 State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine
 Svitlana Revenkova Ph: 38 057 704 10 68
  Email: revenkovasi@mail.ru
 Leonid Vasiliev, MD, Ph.DPrincipal Investigator
  Kiev
 Public Institution: Kiev Regional Oncology Hospital within Kyiv Regional Council
 Petro Halenko, MD Ph: 38 044 489 32 52
  Email: sergadoc@mail.ru
 Petro Halenko, MDPrincipal Investigator
  Kirovohrad
 Kirovohrad Regional Oncology Center, Department of Mammology
 Dmytro Karaskov Ph: 38 0522 24 69 20
  Email: karaskovd@ukr.net
 Kostiantyn Yarynich, MDPrincipal Investigator
  Kryvyi Rih
 Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy
 Natalia Lymar Ph: 38 0675 849195
  Email: natalya.lymar55@yandex.ru
 Hryhorii Adamchuk, MDPrincipal Investigator
  Kyiv
 Kyiv City Oncology Hospital, Department of Chemotherapy
 Oleksandr Voitko Ph: 38 044 221 19 27
  Email: oleksandr.voitko@gmail.com
 Nataliia Voitko, MDPrincipal Investigator
  Lviv
 Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy
 Ivanna Duda Ph: 38 0322 23 14 82
  Email: ivankaduda@ukr.net
 Olha Oleksyak, MDPrincipal Investigator
  Odesa
 Odesa Regional Clinical Hospital, Center for Mastology
 Batyuk Liliya Ph: 38 048 755 8339
  Email: odessaunblin@yandex.ua
 Olkesandr Berzoi, MDPrincipal Investigator
  Uzhhorod
 Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy
 Anna Sochka Ph: 38 03 126 17056
  Email: onkotrial@mail.ru
 Andrii Rusyn, MDPrincipal Investigator
  Vinnytsia
 Vinnytsia Regional Clinical Oncology Center
 Serhii Shevnya Ph: 38 0432 511 160
  Email: shevnya@mail.ru
 Petro Odarchenko, MDPrincipal Investigator
  Zaporizhia
 Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council
 Feroz Shakh, MD Ph: 38 061 287 03 59
  Email: f_shah@ukr.net
 Oleksii Kovaliov, MDPrincipal Investigator
United Kingdom
  Leeds
 Leeds Teaching Hospitals Trust, St. James University Hospital
 Helen Payne Ph: +44 113 206 7999
  Email: helen.payne@leedsth.nhs.uk
 Galina Velikova, ProfPrincipal Investigator
  Leicester
 Leicester Royal Infirmary
 Anita Kang Ph: +44 116 258 7598
  Email: anita-kang@uhl-tr.nhs.uk
 Rahima Ibrahim
  Email: rahima.ibrahim@uhl-tr.nhs.uk
 Ion Boiangiu, MDPrincipal Investigator
  London
 Royal Marsden - London
 Richard Johnson Ph: +44 20 78118206
 Mary O'BrienPrincipal Investigator
  Macclesfield
 Macclesfield District General Hospital
 Lisa Hardstaff
  Email: lisa.hardstaff@nhs.net
 Lisa Barraclough, MDPrincipal Investigator
  Middlesborough
 James Cook University Hospital
 Alison Chilvers, RN Ph: +44 1642 282859
  Email: alison.chilvers@stees.nhs.uk
 John Hardman, MDPrincipal Investigator
  Nottingham
 Academic Unit of Oncology, Nottingham University Hospital-City Campus
 Jo Wright Ph: +44 115 969 1169 Ext.55735
  Email: jo.wright@nuh.nhs.uk
 Stephen Chan, MDPrincipal Investigator
  Plymouth
 Plymouth Oncology Centre, Derriford Hospital
 Julie Pascoe, RN Ph: +44 1752 431958
  Email: julie.pascoe1@nhs.net
 Stephen Kelly, MDPrincipal Investigator
  Sheffield
 Cancer Research Centre at Weston Park Hospital
 Fiona Horwell
  Email: f.j.horwell@sheffield.ac.uk
 Robert Coleman, ProfPrincipal Investigator
  Southampton
 Southampton General Hospital
 Sara Hosseini-Moein Ph: +44 238 079 5157
  Email: s.hosseini-moein@southampton.ac.uk
 Ellen Copson, MDPrincipal Investigator
  Stoke on Trent
 University Hospital of North Staffordshire
 Julie Storer Ph: +44 178 267 2558
  Email: julie.storer@uhns.nhs.uk
 Marion Evans
  Email: marion.evans@uhns.nhs.uk
 Murray Brunt, MDPrincipal Investigator
  Sutton
 Royal Marsden - Surrey
 Mary O'Brien, MD, PhD Ph: +44 20 8642 6011
  Email: mary.obrien@rmh.nhs.uk
 Mary O'BrienPrincipal Investigator
  Withington
 Christie Hospital
 Zoe Brammer Ph: +44 161 446 8408
  Email: zoe.brammer@christie.nhs.uk
 Anne Armstrong, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01479244
ClinicalTrials.gov processed this data on August 07, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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