Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Galena Biopharma, Inc.
Information provided by (Responsible Party):
Galena Biopharma, Inc. Identifier:
First received: November 20, 2011
Last updated: November 25, 2014
Last verified: November 2014

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.

Condition Intervention Phase
HER2 Low to Intermediate Breast Cancer
Biological: NeuVax™ vaccine
Biological: Leukine® (sargramostim, GM-CSF) and water for injection
Phase 3

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

Resource links provided by NLM:

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

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

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

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

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

Estimated Enrollment: 700
Study Start Date: November 2011
Estimated Study Completion Date: June 2024
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Leukine®

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.


  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.


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01479244

Contact: Desiree Hollemon, MSN, MPH 855-855-4253 ext 130
Contact: Lacey Chance 303-722-7768

  Hide Study Locations
United States, Alabama
Alabama Oncology Recruiting
Bessemer, Alabama, United States, 35022
Contact: Brittany White, BBA    205-939-7181   
Principal Investigator: Joanne Rossman, MD         
United States, California
St. Jude Medical Center, Virginia K. Crosson Cancer Center Recruiting
Fullerton, California, United States, 92801
Contact: Gail Torres    714-446-5642   
Principal Investigator: William Lawler, MD         
South Orange County Surgical Medical Group Recruiting
Laguna Hills, California, United States, 92653
Contact: Tracy Bessette    949-680-3490   
Principal Investigator: Kenneth Deck, MD         
Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute Recruiting
Los Angeles, California, United States, 90048
Contact: Suzanne Cabriales, MSN, OCN    310-248-6733   
Principal Investigator: William Audeh, MD         
University of Southern California/Norris Cancer Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Zeno Ashai    323-865-0463   
Principal Investigator: Augustin Garcia, MD         
Moores UC San Diego Cancer Center (UCSD) Recruiting
San Diego, California, United States, 92093
Contact: Jillian McCarthy    858-822-4516   
Principal Investigator: Richard Schwab, MD         
University of California, San Francisco (UCSF), Hellen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Stephanie Ezrati    415-353-7857   
Principal Investigator: Michelle Melisko, MD         
United States, Colorado
University of Colorado Cancer Center, Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Candice Gillmann    720-848-0660   
Principal Investigator: Virginia Borges, MD         
United States, Connecticut
Stamford Hospital, Bennett Cancer Center Withdrawn
Stamford, Connecticut, United States, 06904
United States, Florida
Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Eileen Georgi    954-776-3294   
Principal Investigator: Leonard Seigel, MD         
Cancer Specialists of North Florida (ICON) Recruiting
Jacksonville, Florida, United States, 32256
Contact: Melissa Rammage, MS, RPh    904-519-2731   
Contact: Carol Starr    904-538-3667   
Principal Investigator: Suprith Badarinath, MD         
MD Anderson Center-Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Tina Anderson    321-841-2285   
Principal Investigator: Nikita Shah, MD         
Florida Cancer Research Institute (Florida Cancer Care) Recruiting
Plantation, Florida, United States, 33317
Contact: Dina Hussein, RN, MSN    954-582-1850   
Principal Investigator: Elizabeth Tan-Chiu, MD         
H.Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Katie Fick    813-745-8304   
Principal Investigator: Hatem Soliman, MD         
United States, Georgia
Northeast Georgia Cancer Care Recruiting
Athens, Georgia, United States, 30607
Contact: Jamie Hodgson, CCRC    706-353-2990 ext 279   
Principal Investigator: Petro Nikolinakos, MD         
Central Georgia Cancer Care Recruiting
Macon, Georgia, United States, 31201
Contact: Joanne Kerr, RN    478-743-7068   
Principal Investigator: Frederick Schnell, MD         
United States, Illinois
Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Cesar Santa Maria, MD    312-250-8213   
Principal Investigator: Cesar Santa Maria, MD         
United States, Kansas
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
Contact: Susan Stockton, RN,OCN    316-613-4318   
Principal Investigator: Shaker Dakhil, MD         
United States, Kentucky
James Graham Brown Cancer Center, University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Belma Kantardzic    502-562-4356   
Principal Investigator: Elizabeth Riley, MD         
United States, Louisiana
Mary Bird Perkins Cancer Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Cynthia Knox, RN    225-215-1342   
Principal Investigator: Derrick W Spell, MD         
United States, Maryland
Center of Cancer and Blood Disorders (VEEDA network) Recruiting
Bethesda, Maryland, United States, 20817
Contact: Jessica Kim    301-571-0019   
Principal Investigator: Ralph Boccia, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: David Avigan, MD    617-667-9920   
Principal Investigator: David Avigan, MD         
Lahey Clinic Department of Hematology and Oncology Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Kori Hesse    781-744-3071   
Principal Investigator: Corrine Zarwan, MD         
United States, Michigan
William Beaumont Hospital Cancer Center Recruiting
Royal Oak, Michigan, United States, 48071
Contact: Ruth Fazzari    248-964-9159   
Principal Investigator: Laura Nadeau, MD         
United States, New York
Eastchester Cancer Care Center Recruiting
Bronx, New York, United States, 10469
Contact: Karen Hoffman, MD    718-732-4029   
Principal Investigator: Anthony Hoffman, MD         
Weill Cornell Medical College Recruiting
New York, New York, United States, 100665
Contact: Ellen Chuang, MD    212-821-0644   
Principal Investigator: Ellen Chuang, MD         
United States, North Dakota
St. Alexius Medical Center, Mid Dakota Clinic, PC Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Julie Wetzstein, CCRC    701-530-6960   
Principal Investigator: Jayaram Bharadwaj, MD         
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Knight Clinical Trials Line    503-494-1080   
Principal Investigator: Steve Chui, MD         
United States, Pennsylvania
Conemaugh Memorial Hospital-Memorial Medical Center Recruiting
Johnstown, Pennsylvania, United States, 15905
Contact: Gerard Garguilo, MD    814-539-6797   
Principal Investigator: Gerard Garguilo, MD         
University of Pittsburgh Medical Center (UPMC) Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Brenda Steele    412-641-2261   
Principal Investigator: Adam Brufsky, FACP, MD,PhD         
United States, Tennessee
The West Clinic Recruiting
Memphis, Tennessee, United States, 38120
Contact: Kelly Woodard, MS    901-260-9288   
Principal Investigator: Lee Schwartzberg, MD         
United States, Texas
UT Southwestern Medical Center / Simmons Comprehensive Cancer Center Recruiting
Dallas, Texas, United States, 75390
Contact: Damaris Dotson    214-648-4981   
Principal Investigator: Barbara Haley, MD         
Brooke Army Medical Center (now SAMMC) Recruiting
Ft. Sam Houston, Texas, United States, 78234
Contact: Karen L Arrington, BSN, RN, CCRP    210-243-5711   
Principal Investigator: Nathan M. Shumway, MD, FACP         
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sara E Stassen    713-563-1681   
Principal Investigator: Elizabeth A Mittendorf, MD, FACP         
Baylor College of Medicine Withdrawn
Houston, Texas, United States, 77030
Clinical Trials of Texas, Inc Terminated
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Contact: Nighisti Tewelde    703-894-3810   
Principal Investigator: Nicholas Robert, MD         
United States, Washington
Swedish Cancer Institute Research Recruiting
Seattle, Washington, United States, 98104
Contact: Sarah Fanizzi    206-386-2444   
Contact: Henry Kaplan, MD    206-215-3086   
Principal Investigator: Henry Kaplan, MD         
Multicare Health System-Research Institute Recruiting
Tacoma, Washington, United States, 98405
Contact: Christine Goetz    253-403-7193   
Principal Investigator: Yoshio Inoue, MD         
United States, Wisconsin
Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 52336
Contact: Tina WF Yen, MD, MS    414-805-5495   
Principal Investigator: Tina W Yen, MD, MS         
Central Onco Hospital Recruiting
Plovdiv, Bulgaria, 4002
Contact: Olga Mateva    359 32 990 007   
Principal Investigator: Velko T Minchev, MD         
Serdika Recruiting
Sofia, Bulgaria, 1303
Contact: Nelly Tashkova    359 2 488 99 91   
Principal Investigator: Constanta Timcheva, MD, PhD         
Tsaritsa Yoanna - ISUL Withdrawn
Sofia, Bulgaria, 1527
Complex Oncology Center, Veliko Tarnovo Recruiting
Tarnovo, Bulgaria, 5000
Contact: Miroslava Gancheva    359 62 620 249   
Principal Investigator: Mariya Racheva, MD         
Sveta Marina Recruiting
Varna, Bulgaria, 9010
Contact: Assia Konsoulova, MD    359 52 978 388   
Principal Investigator: Dimitar Kalev, MD, PhD         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G1Z2
Contact: Noor Khattak    780 432 8221   
Principal Investigator: Julie Price Hiller, MD         
Canada, Ontario
Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Diane Robbins    613-737-7700 ext 70302   
Principal Investigator: Roanne J Segal, MD         
Health Sciences North Cancer Centre Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Sue Arklinader    705 522 6237   
Principal Investigator: Scott Young, MD         
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Carolyn Lim    416 480 5000 ext 7219   
Principal Investigator: Kathleen Pritchard, MD         
Canada, Quebec
Hospital Charles LeMorne Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Contact: Veronique Machabee    450 466 5000 ext 3226   
Principal Investigator: Catherine Prady, MD         
Czech Republic
Masaryk Memorial Cancer Institute, Comprehensive Cancer Care Clinic Recruiting
Brno, Czech Republic, 656 53
Contact: Renata Horova, DVM    420 543 136 229   
Principal Investigator: Katarina Petrakova, MD, PhD         
University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy Recruiting
Hradec Kralove, Czech Republic, 500 05
Contact: Simona Sediva    420 495 832 489   
Principal Investigator: Eugen Kubala, MD         
University Hospital Olomouc, Clinic of Oncology Recruiting
Olomouc, Czech Republic, 775 20
Contact: Magda Simkova    420 588 442 522   
Principal Investigator: Bohuslav Melichar, Prof., MD. PhD         
General University Hospital in Prague, Clinic of Oncology Recruiting
Prague 2, Czech Republic, 128 08
Contact: Petra Kalinova    420 224 966 405   
Principal Investigator: Petra Tesarova, Assoc. Prof. MD, PhD         
Institut de Cancérologie de l'Ouest Siet Paul Papin Recruiting
Angers, Cedex 9, France, 49933
Contact: Simon Dupuis    +33 2 44 85 37 57   
Principal Investigator: Sophie Abadie-Lacourtoisie, MD         
Centre Oscar Lambret Recruiting
Cédex, Lille, France, 59020
Contact: Stephanie Clisant    +33 3 2029 5935   
Principal Investigator: Géraldine Lauridant, MD         
Institut de Cancérologie de l'Ouest/René Gauducheau Recruiting
St Herblain, Nantes Cedex, Loire-Atlantique, France, 44805
Contact: Gwenaelle Lewandowski    +33 2 4067 9748   
Principal Investigator: Mario Campone, MD         
Centre Antoine Lacassagne Withdrawn
Nice, France, 06189
Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum Recruiting
Berlin, Germany, 10117
Contact: Joerg Spahrbier    +49 30 450664297   
Principal Investigator: Nikola Bangemann, MD         
Brustzentrum Klinikum Bremen-Mitte gGmbH Recruiting
Bremen, Germany, 28177
Contact: Halil Merdivan    +49 421 497 5361   
Principal Investigator: Mustafa Aydogdu, Dr.         
Universitätsklinikum Erlangen, Frauenklinik Recruiting
Erlangen, Germany, D-91054
Contact: Paul Gass, Dr.    +49 9131 853 3553   
Principal Investigator: Claudia Rauh, MD         
Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Klinik für Senologie/Brustzentrum Recruiting
Essen, Germany, D-45136
Contact: Dorothea Schindowski    +49 201 174 33005   
Contact: Juliane Lubitz   
Principal Investigator: Scherko Kuemmel, MD         
Universitätsklinikum Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe Recruiting
Frankfurt, Germany, 60590
Contact: Stefan Loitsch, Dr    +49 69 6301 6850   
Principal Investigator: Benjamin Schnappauf         
Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie Recruiting
Heidelberg, Germany, 69120
Contact: Monika Fischer    +49 6221-567884   
Principal Investigator: Frederik Marmé, MD         
Universitätsklinikum Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Germany, 24105
Contact: Kirsten Keller    +49 431 597 2084   
Principal Investigator: Christoph Mundhenke, MD         
Universität Marburg Recruiting
Marburg, Germany, 35043
Contact: Klaus Baumann, M.D.    +49 6421 5866491   
Principal Investigator: Klaus Baumann, Dr.         
Rotkreuzklinikum München gGmbH, Frauenklinik Recruiting
Muenchen, Germany, 80637
Contact: Harry Reisch    +49 89 15706 661   
Principal Investigator: Claus A Hanusch, MD         
Universitätsklinikum Münster, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe Recruiting
Münster, Germany, 48149
Contact: Ricarda Haier    +49 251 83 44100   
Principal Investigator: Joke Tio, MD         
Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik Recruiting
Stuttgart, Germany, 70374
Contact: Miriam Alisch    +49 711 278 - 51852   
Principal Investigator: Ulrich Karck, Prof. Dr.         
Klinikum Mutterhaus der Borromaeerinnen Recruiting
Trier, Germany, 54290
Contact: A.R. Waladkhani, Dr.    +49 651 947 2795   
Principal Investigator: Michael Clemens, Prof. MD         
Gemeinschaftspraxis für Innere Medizin, Haematologie und internistische Onkologie Dr. R Schlag/Dr. Schoettker Recruiting
Wuerzburg, Germany, D-97080
Contact: Ursula Reichert    +49 931 322 67108   
Sub-Investigator: Rudolf Schlag, MD         
Principal Investigator: Bjoern Schoettker, MD         
Hetenyi Geza Hospital, Department of Oncology Recruiting
Szolnok, Jasz-Nagykun-Szolnok, Hungary, H-5000
Contact: Kata Nora Papp    36 56 503 603 ext 3321   
Principal Investigator: Tibor Csoszi, MD         
Semmelweis University, Department of Diagnostic Radiology and Oncotherapy Recruiting
Budapest, Hungary, H-1083
Contact: Andrea Makra    36 1 459 1500 ext 51730   
Principal Investigator: Magdolna Dank, MD         
Szent Margit Hospital, V. Department of Internal Medicine, Oncology Withdrawn
Budapest, Hungary, H-1032
Petz Aladar County Teaching Hospital, Center for Oncoradiology Recruiting
Gyor, Hungary, H-9024
Contact: Marta Janoki    36 96 507 972   
Principal Investigator: Tamas Pinter, MD         
Kaposi Mor County Teaching Hospital, Center for Clinical Oncology Recruiting
Kaposvar, Hungary, 7400
Contact: Krisztina Decsi    36 82 501 300   
Principal Investigator: Zoltan Vogyi, MD         
Borsod-Abauj-Zemplen County Hospital and University Educational Hospital, Center for Clinical Oncology and Radiology Recruiting
Miskolc, Hungary, 3526
Contact: Katalin Molnar, MD    36 46 515 200   
Principal Investigator: Katalin Molnar, MD         
Sheba Medical Centre Recruiting
Tel Hasomer, Ramat Gan, Israel, 52621
Contact: Yula Hadzaev    +972 3 3 5307035   
Principal Investigator: Shani Paluch-Shimon, MD.         
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: Anna Isakovitch    +972 4 854 1258   
Principal Investigator: Karen Drumea, MD         
Rabin Medical Centre Recruiting
Petach Tikva, Israel, 49100
Contact: Gal Medalia    +972 2 9378076   
Principal Investigator: Solomon Stemmer, MD         
Kaplan Medical Centre Recruiting
Rehovot, Israel, 76100
Contact: Yael Shaked    +972 8 9441006   
Principal Investigator: Noa Efrat, MD         
Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy Recruiting
Kamienskiego, Wroclaw, Poland, 51-124
Contact: Barbara Ziolkowska    48 71 32 70 453   
Principal Investigator: Beata Freier, MD         
Polish Red Cross Marine Hospital, Department of Chemotherapy Recruiting
Gdynia, Poland, 81-519
Contact: Marta Kasprzak    48 58 72 60 187   
Principal Investigator: Krzysztof Lesniewki-Kmak, MD         
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Chemotheraphy Recruiting
Lodz, Poland, 93-513
Contact: Ewa Kalinka-Warzocha, MD, PhD    48 42 689 5477   
Principal Investigator: Ewa Kalinka-Warzocha, MD, PhD         
Greater Poland Cancer Center, Department of Chemotherapy Recruiting
Poznan, Poland, 61-866
Contact: Lukasz Galus, MD    48 61 88 50 620   
Principal Investigator: Maria Malgorzata Litwiniuk, Assoc Prof., MD, PhD         
Magodent Recruiting
Warsaw, Poland, 04-125
Contact: Tomasz Sarosiek    48 (22) 430 8910   
Principal Investigator: Tomasz Sarosiek, MD         
Non-Public Health Care Facility MAGODENT Recruiting
Warsaw, Poland, 04-125
Contact: Tomasz Sarosiek, M.D. Ph.D.    00 48 22 430 89 20   
Principal Investigator: Tomasz Sarosiek, MD, PhD         
"Gavril Curteanu" Municipal Clinical Hospital Recruiting
Oradea, Bihor, Romania, 410469
Contact: Simona Mihutiu, MD    40 726 729 996   
Principal Investigator: Simona Mihutiu, MD         
Medisprof SRL, Department of Medical Oncology Recruiting
Cluj-Napoca, Cluj, Romania, 400058
Contact: Adrian Udrea, MD    40 751 274 636   
Principal Investigator: Adrian Udrea, MD         
Oncology Center "Sf. Nectarie", Department of Medical Oncology Recruiting
Craiova, Dolj County, Romania, 200347
Contact: Michael Schenker, MD    40 722 161 545   
Principal Investigator: Michael Schenker, MD         
Dr. Constantin Opris County Emergency Hospital, Department of Oncology Recruiting
Baia Mare, Maramures, Romania, 430031
Contact: Filip Dumitru, MD    40 741 074 059   
Principal Investigator: Filip Dumitru, MD         
Coltea Clinical Hospital, Oncology Department Recruiting
Bucharest, Romania, 030171
Contact: Ciprian Aldea, MD    40 722 214 982   
Principal Investigator: Ciprian Aldea, MD         
Bucharest Universtiy Emergency Hosptial, Oncology Department Recruiting
Bucharest, Romania, 050098
Contact: Dan Jinga, MD    40 722 927 377   
Principal Investigator: Dan C Jinga, MD         
Filantropia Clinical Hospital, Obstetrics and Gynaecology Department Recruiting
Bucharest, Romania, 011171
Contact: Prof. Gheorghe Peltecu, MD, PhD    40 744 874 350   
Principal Investigator: Prof. Gheorghe Peltecu, MD, PhD         
"Prof. Dr. Ion Chiricuta" Institute of Oncology Recruiting
Cluj-Napoca, Romania, 400015
Contact: Alexandru Eniu, MD    40 744 523 853   
Principal Investigator: Alexandru Eniu, MD         
Iasi Regional Oncology Institute, Department of Medical Oncology Recruiting
Iasi, Romania, 700483
Contact: Assoc. Prof. Lucian Miron, Dr.    40 744 397 003   
Principal Investigator: Assoc. Prof. Lucian Miron, MD         
Oncomed SRL, Department of Medical Oncology Recruiting
Timisoara, Romania, 300239
Contact: Daniela Sirbu, MD    40 744 571 617   
Principal Investigator: Daniela Sirbu, MD         
Russian Federation
Oncology Center #2, Department of Healthcare of Krasnodar Territory Administration Withdrawn
Sochi, Krasnodar, Russian Federation, 354057
Republican Oncology Center Recruiting
Saransk, Republic of Mordovia, Russian Federation, 430032
Contact: Pavel Skopin, MD    007 927 181 5631   
Principal Investigator: Pavel Skopin, MD         
Republican Clinical Oncoogy Center Recruiting
Kazan, Republic of Tatarstan, Russian Federation, 420029
Contact: Sufia Safina, MD, PhD    007 8435 257 340   
Principal Investigator: Sufia Safina, MD, PhD         
Pyatigorsk Oncology Center Recruiting
Pyatigorsk, Stavropol Region, Russian Federation, 357502
Contact: Vladimir Vladimirov, MD, PhD    007 8793 973 362   
Principal Investigator: Vladimir Vladimirov, MD, PhD, DMedSci         
Arkhangelsk Clinical Oncology Center Recruiting
Arkhangelsk, Russian Federation, 163045
Contact: Natalia Lysova    007 8182 275913   
Principal Investigator: Liudmila Lebedeva, MD         
Scientific Research Center for Oncology and Neurology "Biotherapy" Withdrawn
Berdsk, Russian Federation, 633004
Sverdlovsk Regional Oncology Center Recruiting
Ekaterinburg, Russian Federation, 620036
Contact: Irina Bulavina, MD    007 343 356 15 12   
Principal Investigator: Irina Bulavina, MD         
Regional Oncology Center Recruiting
Irkutsk, Russian Federation, 664035
Contact: Denis Yukalchuk, MD    007 3952 777 283 ext 1062   
Principal Investigator: Denis Yukalchuk, MD         
Ivanovo Regional Oncology Center Recruiting
Ivanovo, Russian Federation, 153040
Contact: Natalya Polyakova, MD    007 4932 565 757   
Principal Investigator: Evgeny Gotovkin, MD         
Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration Recruiting
Krasnodar, Russian Federation, 350040
Contact: Irina Davidenko, MD    007 8612 454 775   
Principal Investigator: Irina Davidenko, MD         
Krasnoyarsk Kryzhanovsky Regional Oncology Center Recruiting
Krasnoyarsk, Russian Federation, 660133
Contact: Natalia Musaeva, MD    007 913 1893995   
Principal Investigator: Prof. Yuri Dykhno, MD, PhD, DMedSc         
Kursk Regional Clinical Oncology Center Recruiting
Kursk, Russian Federation, 305035
Contact: Igor Lifirenko, MD    007 4712 52 95 53   
Principal Investigator: Igor Kiselev, MD         
N.N. Blokhin Russian Cancer Reserach Center Recruiting
Moscow, Russian Federation, 115478
Contact: Lidia Nelyubina, MD    007 495 324 6240   
Principal Investigator: Lidia Nelyubina, MD         
N.N. Blokhin Russian Cancer Research Center Recruiting
Moscow, Russian Federation, 115478
Contact: Maria Rodionova, MD    007 499 152 74 77   
Principal Investigator: Prof. Igor K Vorotnikov, MD, PhD, DMedSci         
Clinical Diagnostics Center Recruiting
Nizhny Novgorod, Russian Federation, 603006
Contact: Prof. Anna Alyasova, MD, PhD, DMedSci    007 831 433 31 09   
Principal Investigator: Prof. Anna Alyasova, MD, PhD, DMedSci         
Nizhny Novgorod Regional Oncology Center Recruiting
Nizhny Novgorod, Russian Federation, 603081
Contact: Olga Tyurina    007 8314 645398   
Principal Investigator: Marina Matrosova, MD         
Orel Oncology Center Recruiting
Orel, Russian Federation, 302020
Contact: Alexander Pecheny, MD    007 4862 763 387   
Principal Investigator: Alexander Pecheny, MD         
Orenburg Regional Clinical Oncology Center Recruiting
Orenburg, Russian Federation, 460051
Contact: Vadim Shirinkin, MD    007 3532 331 135   
Principal Investigator: Vadim Shirinkin, MD         
Medical Institution of Ryazan Region Recruiting
Ryazan, Russian Federation, 390011
Contact: Marina Shomova, MD    007 4912 270 514   
Principal Investigator: Marina Shomova, MD         
Samara Regional Clinical Oncology Center Recruiting
Samara, Russian Federation, 443031
Contact: Anastasia Pankova    8 8469 947650   
Principal Investigator: Prof. Mikhail Kopp, MD, PhD, DMedSci         
Petrov Research Institute of Oncology Recruiting
St Petersburg, Russian Federation, 197758
Contact: Olga Ivanova, MD    007 812 670 76 38   
Principal Investigator: Olga Ivanova, MD, PhD         
Municipal Clinical Oncology Center Recruiting
St. Petersburg, Russian Federation, 198255
Contact: Lada Selezneva, MD    007 812 2341983   
Principal Investigator: Alexey Manikhas, MD         
Mechnikov North-Western State Medical University Recruiting
St. Petersburg, Russian Federation, 195067
Contact: Sevda Sadygova, MD    007 921 6360332   
Principal Investigator: Eldar Topuzov, MD, PhD, DMedSci         
Leningrad Regional Oncology Center Recruiting
St. Petersburg, Russian Federation, 191104
Contact: Anna Vats    007 812 945 33 18   
Principal Investigator: Dmitriy Krasnozhon, MD, PhD         
St. Petersburg Clinical Hospital Recruiting
St. Petersburg, Russian Federation, 194017
Contact: Anna Buiniakova, MD    007 812 293 9087   
Principal Investigator: Anna Buiniakova, MD         
Tambov Regional Clinical Oncology Center Recruiting
Tambov, Russian Federation, 392013
Contact: Anton Tischenko, MD    007 4752 725 351   
Principal Investigator: Vladimir Milovanov, MD         
Research Institute of Oncology Not yet recruiting
Tomsk, Russian Federation, 634028
Contact: Prof. Elena Slonimskaya, MD, PhD    007 3822 41 80 92   
Principal Investigator: Prof. Elena Slonimskaya, MD, PhD, DMedSci         
Bashkir State Medical University Recruiting
Ufa, Russian Federation, 450000
Contact: Viktoria Kononova, MD    007 347 324 34 13   
Principal Investigator: Adel Izmailov, MD         
Regional Clinical Oncology Center Recruiting
Veliky Novgorod, Russian Federation, 173016
Contact: Vladimir Ivanchenko, MD    007 921 731 7047   
Principal Investigator: Vladimir Ivanchenko, MD         
Volgograd Regional Oncology Center #3 Recruiting
Volzhskiy, Russian Federation, 404130
Contact: Evgeny Rusanov    007 928 370 8244   
Principal Investigator: Nadezhda Kovalenko, MD, PhD         
Yaroslavl Regional Oncology Center Recruiting
Yaroslavl, Russian Federation, 150054
Contact: Marina Shultishova    007 4852 721 044   
Principal Investigator: Sergey Cheporov, MD, PhD         
Clinical Diagnostics Center Withdrawn
Simferopol, Autonomous Republic of Crimea, Ukraine, 95000
Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy Recruiting
Kryvyi Rih, Dnipropetrovsk Region, Ukraine, 50000
Contact: Natalia Lymar    38 0675 849195   
Principal Investigator: Hryhorii Adamchuk, MD         
Mariupol City Interdistrict Oncology Center, Surgery Department #2 Suspended
Mariupol, Donetsk Region, Ukraine, 87500
Kharkiv Regional Clinical Oncology Center, Day Care Unit Recruiting
Kharkiv, Kyivskyi District, Ukraine, 61070
Contact: Natalia Krizhanivska    38 057 311 80 36   
Principal Investigator: Yurii Vinnyk, MD, DMedSc, Prof.         
Chernivtsi Regional Clinical Oncology Center, Day Care Unit Recruiting
Chernivtsi, Ukraine, 58013
Contact: Hontsa Iryna, MD    38 0372 547 650   
Principal Investigator: Anatolii Oleksandrovych Hontsa, MD, PhD, Assoc. Prof.         
Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy Recruiting
Dnipropetrovsk, Ukraine, 49102
Contact: Yuliia Yarosh    38 0562 585 372   
Principal Investigator: Prof. Ihor Bondarenko, MD, PhD, DMedSci         
Donetsk City Oncology Center Withdrawn
Donetsk, Ukraine, 83087
Donetsk Regional Antitumor Center, Oncosurgery Department #2 Withdrawn
Donetsk, Ukraine, 83092
State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine Withdrawn
Kharkiv, Ukraine, 61024
Public Institution: Kiev Regional Oncology Hospital within Kyiv Regional Council Recruiting
Kiev, Ukraine, 04107
Contact: Petro Halenko, MD    38 044 489 32 52   
Principal Investigator: Petro Halenko, MD         
Kirovohrad Regional Oncology Center, Department of Mammology Recruiting
Kirovohrad, Ukraine, 25011
Contact: Dmytro Karaskov    38 0522 24 69 20   
Principal Investigator: Kostiantyn Yarynich, MD         
Kyiv City Clinical Oncology Center, Department of Chemotherapy Withdrawn
Kyiv, Ukraine, 03115
Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy Recruiting
Lviv, Ukraine, 79031
Contact: Ivanna Duda    38 0322 23 14 82   
Principal Investigator: Olha Oleksyak, MD         
Odesa Regional Clinical Hospital, Center for Mastology Recruiting
Odesa, Ukraine, 65000
Contact: Batyuk Liliya    38 048 755 8339   
Principal Investigator: Olkesandr Berzoi, MD         
Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy Recruiting
Uzhhorod, Ukraine, 88014
Contact: Anna Sochka    38 03 126 17056   
Principal Investigator: Andrii Rusyn, MD, DMedSc, Prof         
Vinnytsia Regional Clinical Oncology Center Recruiting
Vinnytsia, Ukraine, 21029
Contact: Sergii Shevnya, MD    38 0432 511 160   
Principal Investigator: Sergii Shevnya, MD         
Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council Withdrawn
Zaporizhia, Ukraine, 69040
United Kingdom
Macclesfield District General Hospital Recruiting
Macclesfield, Cheshire, United Kingdom, SK10 3BL
Contact: Lisa Hardstaff   
Principal Investigator: Lisa Barraclough, MD         
The Christie NHS Foundation Trust Recruiting
Withington, Manchester, United Kingdom, M20 4BX
Contact: Zoe Brammer    +44 161 446 8408   
Principal Investigator: Anne Armstrong, MD         
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Mary O'Brien, MD, PhD    +44 20 8642 6011   
Principal Investigator: Mary O'Brien, MD         
Leeds Teaching Hospitals Trust, St. James University Hospital Recruiting
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Contact: Helen Payne    +44 113 206 7999   
Principal Investigator: Galina Velikova, Prof         
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Contact: Anita Kang    +44 116 258 7598   
Contact: Rahima Ibrahim   
Principal Investigator: Ion Boiangiu, MD         
The Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Contact: Richard Johnson    +44 20 78118206      
Principal Investigator: Mary O'Brien, MD         
James Cook University Hospital Recruiting
Middlesborough, United Kingdom, TS4 3BW
Contact: Alison Chilvers, RN    +44 1642 282859   
Principal Investigator: John Hardman, MD         
Academic Unit of Oncology, Nottingham University Hospital-City Campus Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Jo Wright    +44 115 969 1169 ext 55735   
Principal Investigator: Stephen Chan, MD         
Plymouth Oncology Centre, Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: Julie Pascoe, RN    +44 1752 431958   
Principal Investigator: Stephen Kelly, MD         
Weston Park Hospital Recruiting
Sheffield, United Kingdom, S10 2SJ
Contact: Fiona Horwell   
Principal Investigator: Robert Coleman, Prof         
Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Sara Hosseini-Moein    +44 238 079 5157   
Principal Investigator: Ellen Copson, MD         
University Hospital of North Staffordshire Recruiting
Stoke on Trent, United Kingdom, ST4 6QG
Contact: Julie Storer    +44 178 267 2558   
Contact: Marion Evans   
Principal Investigator: Murray Brunt, MD         
Sponsors and Collaborators
Galena Biopharma, Inc.
Principal Investigator: Elizabeth A Mittendorf, MD,FACS M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: Galena Biopharma, Inc. Identifier: NCT01479244     History of Changes
Other Study ID Numbers: NeuVax™ PH3-01, BB-IND 009187, 2011-005219-98
Study First Received: November 20, 2011
Last Updated: November 25, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on March 03, 2015