Efficacy and Safety Study of NeuVax(TM)(Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)
This study is currently recruiting participants.
Verified May 2013 by Galena Biopharma, Inc.
Sponsor:
Galena Biopharma, Inc.
Information provided by (Responsible Party):
Galena Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT01479244
First received: November 20, 2011
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
Purpose of this trial:
- To assess the efficacy and safety of NeuVax(TM)a peptide (E75) vaccine administered with adjuvant Leukine(R)(sargramostim,GM-CSF).
- To evaluate and compare the disease free survival (DFS) in the vaccinated patients and control patients.
| Condition | Intervention | Phase |
|---|---|---|
|
HER2 Negative 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: | Prevention of Recurrence in Early-Stage,Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax(TM) Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Sargramostim
U.S. FDA Resources
Further study details as provided by Galena Biopharma, Inc.:
Primary Outcome Measures:
- Comparison of disease-free survival in vaccine treated patients and control patients [ Time Frame: 36 months ] [ Designated as safety issue: No ]The primary objective is to compare the disease-free survival (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 (sargramostim, GM-CSF) as the control group.
Secondary Outcome Measures:
- Assessment of Disease-Free Survival and Overall Survival 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 Overall survival (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: | May 2022 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NeuVax vaccine
NeuVax [E75 acetate in WFI solution with Leukine(R)(sargramostim,GM-CSF)
|
Biological: NeuVax vaccine
E75 peptide acetate (HER2/neu p366-379) in Water for Injection (WFI, 1.5 mg/mL mixed with 250 microgram Leukine (sargramostim, GM-CSF), for intradermal injections administered once a month for six months, followed by booster inoculations administered once every six months for five additional injections.
Other Name: E75 peptide acetate , WFI, sargramostim, GM-CSF
|
|
Active Comparator: Control
Control: Leukine(GM-CSF, sargramostim)with Water for injection
|
Biological: Leukine (sargramostim, GM-CSF) and water for injection
Leukine 250 microgram in water for injection, monthly intradermal injections for six months, followed by booster inoculations administered once every six months for five additional injections.
Other Name: Leukine(R)
|
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 (NP) 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 with physician prescribed endocrine treatment.
The NeuVax 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).
The active portion of the study will last three years (36 months). The follow-up will last from 5 to 10 years.
Endpoints:
- The primary efficacy endpoint is comparing Disease-Free Survival (DFS) in treatment group versus control group.
The secondary efficacy endpoints are
- 5- and 10-year (disease free survival) DFS
- 3-year overall survival (OS)
- 5- and 10-year overall survival (OS), and Overall safety profile and adverse events (AEs)
Safety Assessments:
Patients 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Women, 18 years of age and higher
- Pathological diagnosis of invasive adenocarcinoma of the breast
- Breast cancer completely excised
- Node-positive disease
- Primary tumor stage T1-3
- 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
Key Exclusion Criteria:
- Bilateral breast malignancy or suspicious mass in opposite breast
- 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
- Patients on chronic steroid therapy, other immunosuppressive therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479244
Hide Study Locations
Contacts
| Contact: Lynn Sutton, RN, MA | +1 855.855.4253 ext 113 | lsutton@galenabiopharma.com |
| Contact: Allan A Valmonte | +1.503.400.6624 | avalmonte@galenabiopharma.com |
Hide Study LocationsLocations
| United States, Alabama | |
| Alabama Oncology | Recruiting |
| Bessemer, Alabama, United States, 35022 | |
| Contact: Lisa Moore 205-803-4389 lisa.moore@alabamaoncology.com | |
| Principal Investigator: Joanne Rossman, MD | |
| United States, California | |
| St. Jude Medical Center, Virginia K. Crosson Cancer Center | Recruiting |
| Fullerton, California, United States, 92801 | |
| Contact: Teresa Olea, RN 714-446-5364 teresa.olea@stjoe.org | |
| Principal Investigator: William Lawler, MD | |
| South Orange County Surgical Medical Group | Recruiting |
| Laguna Hills, California, United States, 92653 | |
| Contact: Tracy Bessette 949-457-7900 tbessette@socsmgresearch.com | |
| 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 swains@cshs.org | |
| 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 zeno.ashai@med.usc.edu | |
| 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 jmccarthy@ucsd.edu | |
| 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 EzratiS@cc.ucsf.edu | |
| 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 candice.gillmann@ucdenver.edu | |
| Principal Investigator: Virginia Borges, MD | |
| United States, Connecticut | |
| Stamford Hospital, Bennett Cancer Center | Recruiting |
| Stamford, Connecticut, United States, 06904 | |
| Contact: Mary Miller 203-964-8472 mmiller@stamhealth.org | |
| Principal Investigator: Paul Weinstein, MD | |
| United States, Florida | |
| Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center | Recruiting |
| Fort Lauderdale, Florida, United States, 33308 | |
| Contact: Lorrain Hickson 954-267-7750 lorraine.hickson@holy-cross.com | |
| 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 melissa.ramage@cancerspecialistsnf.com | |
| Principal Investigator: Suprith Badarinath, MD | |
| MD Anderson Center-Orlando health | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Monica Drouillard, RN 321-841-2285 monica.drouillard@orlandohealth.com | |
| 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 crc@flcancercare.com | |
| Principal Investigator: Elizabeth Tan-Chiu, MD | |
| H.Lee Moffitt Cancer Center and Research Institute | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Dawn Carney 813-745-1807 dawn.carney@moffitt.org | |
| Principal Investigator: Hatem Soliman, MD | |
| United States, Georgia | |
| Central Georgia Cancer Care | Recruiting |
| Macon, Georgia, United States, 31201 | |
| Contact: Joanne Kerr, RN 478-743-7068 jkerr@centralgacancercare.com | |
| 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: Jacqueline S. Jeruss, MD, PhD 312-503-4236 j-jeruss@northwestern.edu | |
| Principal Investigator: Jacqueline S. Jeruss, MD, PhD | |
| United States, Kansas | |
| Cancer Center of Kansas | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Susan Stockton, RN,OCN 316-613-4318 susan.stockton@cancercenterofkansas.com | |
| 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 502-852-7997 bnkant01@louisville.edu | |
| Principal Investigator: Elizabeth Riley, MD | |
| United States, Louisiana | |
| Mary Bird Perkins Cancer Center | Recruiting |
| Baton Rouge, Louisiana, United States, 70809 | |
| Contact: Donna Holmes 225-215-1185 dholmes@marybird.com | |
| Principal Investigator: Derrick W Spell, MD | |
| United States, Maryland | |
| Center of Cancer and Blood Disorders (VEEDA network) | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| Contact: Christine DiSilvestre, RN,BSN 301-571-2016 cdisilvestre@ccbdmd.com | |
| 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 davigan@bidmc.harvard.edu | |
| Principal Investigator: David Avigan, MD | |
| Lahey Clinic Department of Hematology and Oncology | Recruiting |
| Burlington, Massachusetts, United States, 01805 | |
| Contact: Kori Hesse 781-744-3071 kori.hesse@lahey.org | |
| Principal Investigator: Corrine Zarwan, MD | |
| United States, New York | |
| Eastchester Cancer Care Center | Recruiting |
| Bronx, New York, United States, 10469 | |
| Contact: Karen Hoffman, MD 718-732-4029 karen@eastchestercenter.com | |
| Principal Investigator: Anthony Hoffman, MD | |
| Weill Cornell Medical College | Recruiting |
| New York, New York, United States, 100665 | |
| Contact: Ellen Chuang, MD 212-821-0644 elc2007@med.cornell.edu | |
| 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 jwetzstein@primecare.org | |
| Principal Investigator: Jayaram Bharadwaj, MD | |
| United States, Oregon | |
| OHSU Knight Cancer Institute | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Deirdre Nauman, RN 503-494-3078 naumand@ohsu.edu | |
| 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 ggargui@conemaugh.org | |
| Principal Investigator: Gerard Garguilo, MD | |
| Univerity of Pittsburgh Medical Center (UPMC) Cancer Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Brenda Steele 412-641-2281 steebx@upmc.edu | |
| 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 kwoodard@theacornnetwork.com | |
| 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 damaris.dotson@utsouthwestern.edu | |
| 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 210-916-4837 karen.l.arrington.ctr@us.army.mil | |
| Principal Investigator: Nathan M. Shumway, MD, FACP | |
| University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Sara E Stassen 713-792-2362 SEStassen@mdanderson.org | |
| Principal Investigator: Elizabeth A Mittendorf, MD, FACP | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Laura R O'Rosky, BS 713-798-1975 orosky@bcm.edu | |
| Principal Investigator: Mothaffer Rimawi, MD | |
| Clinical Trials of Texas, Inc | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Kay Scroggins, RN 210-949-0122 kscroggins@cttexas.com | |
| Principal Investigator: Slavisa Gasic, MD | |
| United States, Virginia | |
| Virginia Cancer Specialists | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| Contact: Kay Scott 703-208-3160 kay.scott@usoncology.com | |
| Principal Investigator: Nicholas Robert, MD | |
| United States, Washington | |
| Swedish Cancer Institute Research | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Sarah Fanizzi 206-386-2444 sarah.fanizzi@swedish.org | |
| Contact: Henry Kaplan, MD 206-215-3086 SwedishCancerResearch@swedish.org | |
| Principal Investigator: Henry Kaplan, MD | |
| Multicare Health System-Research Institute | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Christine Goetz 253-403-7193 christine.goetz@multicare.org | |
| 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 tyen@mcw.edu | |
| Principal Investigator: Tina W Yen, MD,MS | |
| Bulgaria | |
| Central Onco Hospital | Recruiting |
| Plovdiv, Bulgaria, 4002 | |
| Contact: Olga Mateva 359 32 990 007 olga_mateva@yahoo.com | |
| Principal Investigator: Velko T Minchev, MD | |
| Tsaritsa Yoanna - ISUL | Recruiting |
| Sofia, Bulgaria, 1527 | |
| Contact: Radoslava Ilieva 359 2 943 22 29 radoslava_ilieva@abv.bg | |
| Principal Investigator: Asen P Dudov, MD, PhD | |
| Serdika | Recruiting |
| Sofia, Bulgaria, 1303 | |
| Contact: Magdalena Mratsendova 359 2 488 99 91 ctimcheva12@gmail.com | |
| Principal Investigator: Constanta Timcheva, MD, PhD | |
| Veliko Tarnovo | Recruiting |
| Tarnovo, Bulgaria, 5000 | |
| Contact: Miroslava Gancheva 359 62 620 249 onkovt@abv.bg | |
| Principal Investigator: Mariya Racheva, MD | |
| Sveta Marina | Recruiting |
| Varna, Bulgaria, 9010 | |
| Contact: Svetla Drumeva 359 52 978 388 lotu@abv.bg | |
| Principal Investigator: Dimitar Kalev, MD, PhD | |
| Canada, Alberta | |
| Cross Cancer Institute | Recruiting |
| Edmonton, Alberta, Canada, T6G1Z2 | |
| Contact: Noor Khattak 780 577 8072 noor.khattak@albertahealthservices.ca | |
| Principal Investigator: Julie P Hiller, MD | |
| Canada, Ontario | |
| Health Sciences North Cancer Centre | Recruiting |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Contact: Janet Dakins 705 522 6237 ext 2532 jdakins@hsnsudbury.ca | |
| Principal Investigator: Andrew Robinson, MD | |
| Sunnybrook Research Institute | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Carolyn Lim 416 480 5000 ext 7219 carolyn.lim@sunnybrook.ca | |
| 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 veronique.machabee@rrsss16.gouv.qc.ca | |
| Principal Investigator: Catherine Prady, MD | |
| Czech Republic | |
| Hdradec Kralove Clinical of Oncology and Radiotherapy | Recruiting |
| Hradec Kralove, Czech Republic | |
| Contact: Simona Mudrunkova 420 495 832 489 siimona.mudrunkova@fnhk.cz | |
| Principal Investigator: Eugen Kubala, MD | |
| Olomouc Clinic of Oncology | Recruiting |
| Olomouc, Czech Republic | |
| Contact: Bohuslav Melichar, MD 420 588 444 295 bohuslav.melichar@fnol.cz | |
| Principal Investigator: Bohuslav Melichar, MD | |
| Hungary | |
| Hetenyi Geza Hospital, Department of Oncology | Recruiting |
| Szolnok, Jasz-Nagykun-Szolnok, Hungary, H-5000 | |
| Contact: Aniko Eke 3-56/503-603 ext. 3321 eke.aniko@teletechnik.hu | |
| Principal Investigator: Tibor Csoszi, MD | |
| Szent Margit Hospital, V. Department of Internal Medicine, Oncology | Recruiting |
| Budapest, Hungary, H-1032 | |
| Contact: Zsuzsanna Toth 36 1 250 2420 zsuzsanna.toth@coordination.hu | |
| Principal Investigator: Katalin Boer, MD | |
| Semmelweis University, Department of Diagnostic Radiology and Oncotherapy | Recruiting |
| Budapest, Hungary, H-1082 | |
| Contact: Andrea Makra 36 1 459 4500 trial.sote@gmail.com | |
| Principal Investigator: Magdolna Dank, MD | |
| Petz Aladar County Teaching Hospital, Center for Oncoradiology | Recruiting |
| Gyor, Hungary, H-9024 | |
| Contact: Marta Janoki 3696 418 244 janoki.m@gmail.com | |
| 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 decsikriszta@gmail.com | |
| 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: Monika Szilagyi 36 46/515-200 szilagyim@bazmkorhaz.hu | |
| Principal Investigator: Katalin Molnar, MD | |
| Israel | |
| Rabin Medical Centre | Recruiting |
| Petach Tikva, Israel, 49100 | |
| Contact: Gal Medalia 972 2 9378076 galmed@clalit.org.il | |
| Principal Investigator: Solomon Stemmer, MD | |
| Kaplan Medical Centre | Recruiting |
| Rehovot, Israel, 76100 | |
| Contact: Yael Shaked 972 8 9441006 yaelsha@clalit.org.il | |
| Principal Investigator: Noa Efrat, MD | |
| Sheba Medical Centre | Recruiting |
| Tel Hasomer, Israel, 52621 | |
| Contact: Yula Hadzaev 972 3 3 5307035 yula.hadzaev@sheba.health.gov.il | |
| Principal Investigator: Bella Kaufman, Professor | |
| Poland | |
| Greater Poland Cancer Center, Department of Chemotherapy | Recruiting |
| Poznan, Poland, 61-866 | |
| Contact: Dominika Swietlik 48 61 88 50 694 dominika.szymanska@wp.pl | |
| Principal Investigator: Piotr Wysocki, MD, PhD | |
| Romania | |
| Teo Health SA (Saint Constantin Private Hosptial | Recruiting |
| Brasov, Brasov County, Romania | |
| Contact: Adela Banu 00 40 268 300 326 adela.banu@spitalulsfconstantin.ro | |
| Principal Investigator: Eugeniu Banu, MD | |
| SC Medisprof SRL, Department of Medical Oncology | Recruiting |
| Cluj-Napoca, Cluj County, Romania | |
| Contact: Amalia Danila 00 40 264 439 270 amaliadanila@medisprof.ro | |
| Principal Investigator: Adrian Udrea, MD | |
| Oncolab SRL | Recruiting |
| Craiova, Dolj County, Romania | |
| Contact: Denis Diaconescu 00 40 251 531 088 denis.diaconescu@yahoo.com | |
| Principal Investigator: Dan Lungulescu, MD | |
| Filantropia Clinical Hospital, Obstetrics and Gynaecology Department | Recruiting |
| Bucharest, Sector 1, Romania | |
| Contact: Dragos Median 00 40 213 188 937 dragos.median@gmail.com | |
| Principal Investigator: Gheorghe Peltecu, MD | |
| Coltea Clinical Hospital, Oncology Department | Recruiting |
| Bucharest, Romania | |
| Contact: Ileana Raluca Patru raluca.patru@gmail.com | |
| Principal Investigator: Ciprian Aldea | |
| Bucharest Universtiy Emergency Hosptial, Oncology Department | Recruiting |
| Bucharest, Romania | |
| Contact: Diana Chetroiu 00 40 213 11 55 51 diachet83@yahoo.com | |
| Principal Investigator: Dan C Jinga, MD | |
| Russian Federation | |
| Oncology Center #2, Department of Healthcare of Krasnodar Territory Administration | Recruiting |
| Sochi, Krasnodar Territory, Russian Federation, 354057 | |
| Contact: Natalia Shapovalova 8 918 6113855 sochitrials@gmail.com | |
| Principal Investigator: Dmitry Udovitsa, MD | |
| Republican Clinical Oncoogy Center | Recruiting |
| Kazan, Republic of Tatarstan, Russian Federation, 420029 | |
| Contact: Rezeda Galimova, MD 8 8435 257337 | |
| Principal Investigator: Sufia Safina, MD | |
| Pyatigorsk Oncology Center | Recruiting |
| Pyatigorsk, Stavropol Region, Russian Federation, 357502 | |
| Contact: Elena Suprovich 8 918 7613979 elene.suprovich@rambler.ru | |
| Principal Investigator: Vladimir Vladimirov, MD | |
| Arkhangelsk Clinical Oncology Center | Recruiting |
| Arkhangelsk, Russian Federation, 163045 | |
| Contact: Veronika Zagurskaya 8 8182 275913 chemother29@yandex.ru | |
| Principal Investigator: Liudmila Lebedeva, MD | |
| Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration | Recruiting |
| Krasnodar, Russian Federation, 350040 | |
| Contact: Olga Esipenko 8 918 9909501 gersimi@rambler.ru | |
| Principal Investigator: Irina Davidenko, MD | |
| Krasnoyarsk State Medical University, Regional Clinical Oncology Center, A.I. Kryzhanovskiy | Recruiting |
| Krasnoyarsk, Russian Federation, 660022 | |
| Contact: Natalia Musaeva 7 913 1893995 musa-eva100@mail.ru | |
| Principal Investigator: Yuri Dykhno, Professor | |
| Kursk Regional Clinical Oncology Center | Recruiting |
| Kursk, Russian Federation, 305035 | |
| Contact: Anna Konoreva 8 951 0792994 pikood46@gmail.com | |
| Principal Investigator: Igor Kiselev, MD | |
| Lipetsk Regional Oncology Center | Recruiting |
| Lipetsk, Russian Federation, 398005 | |
| Contact: Elena Kozlovskaya, MD 8 (903) 8613188 kozlovskaya.lena2011@yandex.ru | |
| Principal Investigator: Sergey Shinkarev, MD | |
| N.N. Blokhin Russian Cancer Research Center | Recruiting |
| Moscow, Russian Federation, 115478 | |
| Contact: Nino Chkhikvadze 8(903)122 3718 ninochkhi@mail.ru | |
| Principal Investigator: Igor K Vorotnikov, Professor | |
| N.N. Blokhin Russian Cancer Reserach Center | Recruiting |
| Moscow, Russian Federation, 115478 | |
| Contact: Lidia Neiyubina, MD 8(495)324 6240 lydia.a.n@yandex.ru | |
| Principal Investigator: Lidia Neiyubina, MD | |
| Nizhny Novgorod Regional Oncology Center | Recruiting |
| Nizhny Novgorod, Russian Federation, 603081 | |
| Contact: Olga Tyurina 8 8314 645398 lolo5252@mail.ru | |
| Principal Investigator: Marina Matrosova, MD | |
| Municipal Clinical Hospital #1 | Recruiting |
| Novosibirsk, Russian Federation, 630047 | |
| Contact: Vitaliy Karnaukhov 8 (983) 2492951 vitaly.karnaukhov@gmail.com | |
| Principal Investigator: Sergey Sidorov, Professor | |
| Orel Oncology Center | Recruiting |
| Orel, Russian Federation, 302020 | |
| Contact: Svetlana Toropova 8 (4862) 763387 himio5@mail.ru | |
| Principal Investigator: Alexander Pencheniy, MD | |
| Medical Institution of Ryazan Region | Recruiting |
| Ryazan, Russian Federation, 390011 | |
| Contact: Igor Viktorov, MD 8 4912 453018 victorovdoc@mail.ru | |
| Principal Investigator: Marina Shomova, MD | |
| Samara Regional Clinical Oncology Center | Recruiting |
| Samara, Russian Federation, 443031 | |
| Contact: Anastasia Pankova 8 8469 947650 sokod70@mail.ru | |
| Principal Investigator: Mikhail Kopp, Professor | |
| Research Institute of Oncology | Recruiting |
| St Petersburg, Russian Federation, 197758 | |
| Contact: Marina Baeva 8(921)634 6080 marina-mammolog@mail.ru | |
| Principal Investigator: Olga Ivanova, MD | |
| Leningrad Regional Oncology Center | Recruiting |
| St. Petersburg, Russian Federation, 188663 | |
| Contact: Tatiana V Potetyruina 8(921)940 1543 pottat@mail.ru | |
| Principal Investigator: Dmitriy Krasnozhon, MD | |
| North-Western State Medical University | Recruiting |
| St. Petersburg, Russian Federation, 195067 | |
| Contact: Sevda Sadygova, MD 8 921 6360332 sevda78@yandex.ru | |
| Principal Investigator: Eldar Topuzov, MD | |
| St. Petersburg Clinical Hospital/Russian Academy of Sciences | Recruiting |
| St. Petersburg, Russian Federation, 194017 | |
| Contact: Anna Buiniakova, MD 8(812)293 9087 anna.bnk@mail.ru | |
| Principal Investigator: Anna Buiniakova, MD | |
| Municipal Clinical Oncology Center | Recruiting |
| St. Petersburg, Russian Federation, 198255 | |
| Contact: Lada Selezneva, MD 8 921 339 9938 ladayana@mail.ru | |
| Principal Investigator: Alexey Manikhas, MD | |
| Ivanovo Regional Oncology Center | Recruiting |
| St. Petersburg, Russian Federation, 197758 | |
| Contact: Olga Smirnova 8 920 6711492 smirnovaolga74@yandex.ru | |
| Principal Investigator: Evgeny Gotovkin | |
| Stavropol Regional Clinical Oncology Center | Recruiting |
| Stavropol, Russian Federation, 355047 | |
| Contact: Philipp Scherbinin 8(4712)547834 philippstav@gmail.com | |
| Principal Investigator: Natalia Levchenko, MD | |
| Tambov Regional Clinical Oncology Center | Recruiting |
| Tambov, Russian Federation, 392013 | |
| Contact: Oleg Mironov 8 915 6661709 mironov_onko@mail.ru | |
| Principal Investigator: Vladimir Milovanov, MD | |
| Bashkir State Medical University | Recruiting |
| Ufa, Russian Federation, 450000 | |
| Contact: Viktoria Kononova 8 347 3243413 kochanova21@mail.ru | |
| Principal Investigator: Adel Izmailov | |
| Sverdlovsk Regional Oncology Center | Recruiting |
| Yaroslavl, Russian Federation, 150054 | |
| Contact: Marina Shultishova 8 4852 721044 mshultishova@rambler.ru | |
| Principal Investigator: Sergey Cheporov | |
| Sverdlovsk Regional Oncology Center | Recruiting |
| Yaroslavl, Russian Federation, 620036 | |
| Contact: Dvgeniy Grebenev, MD 8 (343) 356 17 44 grebenev_evgenii@mail.ru | |
| Principal Investigator: Irina Bulavina, MD | |
| Ukraine | |
| Clinical Diagnostics Center | Recruiting |
| Simferopol, Autonomous Republic of Crimea, Ukraine, 95000 | |
| Contact: Amdiev Selim 38 066 2112880 amdiev@mail.ru | |
| Principal Investigator: Bekir Dzhelialovych Seferov, MD | |
| Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy | Recruiting |
| Kryvyi Rih, Dnipropetrovsk Region, Ukraine, 50000 | |
| Contact: Natalia Lymar 38 0675 849195 natalya.lymar55@yandex.ru | |
| Principal Investigator: Hryhorii Anatoliiovych Adamchuk, MD | |
| Mariupol City Interdistrict Oncology Center, Surgery Department #2 | Recruiting |
| Mariupol, Donetsk Region, Ukraine, 87500 | |
| Contact: Dudarovska Hanna 8 0629 347517 dudarovska@rambler.ru | |
| Principal Investigator: Serhij Petrovych Voloshyn | |
| Kharkiv Regional Clinical Oncology Center, Day Care Unit | Recruiting |
| Kharkiv, Kyivskyi District, Ukraine, 61070 | |
| Contact: Natalia Krizhanivska 38 050 820 6544 natali.krz@gmail.com | |
| Principal Investigator: Yurii Oleksiiovych Vinnyk, MD | |
| Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy | Recruiting |
| Uzhhorod, Zakarpatskiy Region, Ukraine, 88014 | |
| Contact: Laponog Luidmila 3803 126 17056 onkotrial@mail.ru | |
| Principal Investigator: Andrii Vasyliovych Rusyn | |
| Chernihiv Regional Oncology Center, Department of Mamology | Recruiting |
| Chernihiv, Ukraine, 14029 | |
| Contact: Bardakov Hryhorii 38046 2259049 bhrygoriy@yahoo.com | |
| Principal Investigator: Serhii Eduardovych Polenkov, MD | |
| Chernivtsi Regional Clinical Oncology Center, Day Care Unit | Recruiting |
| Chernivtsi, Ukraine, 58013 | |
| Contact: Hontsa Iryna (0372)547650 iryna.hontsa@gmail.com | |
| Principal Investigator: Anatolii Oleksandrovych Hontsa, MD | |
| Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy | Recruiting |
| Dnipropetrovsk, Ukraine, 49102 | |
| Contact: Maltseva Lubov 38(0562)585372 oncology@dsma.dp.ua | |
| Principal Investigator: Ihor Mykolaiovych Bondarenko, MD | |
| Donetsk Regional Antitumor Center, Oncosurgery Department #2 | Recruiting |
| Donetsk, Ukraine, 83000 | |
| Contact: Ihor Diedakov 380 623 867468 drrost2@gmail.com | |
| Principal Investigator: Alieva Svitlana Oktaivna, MD | |
| Ivano-Frankivsk Regional Oncology Center, Clinical Center for Mastology with Urology Wards | Recruiting |
| Ivano-Frankivsk, Ukraine, 76000 | |
| Contact: Teren Tetyana 380 342 775477 teren70@inbox.ru | |
| Principal Investigator: Ipolyt Yuliiovych Kostinskyi | |
| Khmelnytskyi Regional Oncology Center | Recruiting |
| Khmelnytskyi, Ukraine, 29009 | |
| Contact: Drobner Hanna 38(0382)654859 drobdoc2007@mail.ru | |
| Principal Investigator: Ihor Hariiovych Drobner, MD | |
| Kirovohrad Regional Oncology Center, Department of Mammology | Recruiting |
| Kirovohrad, Ukraine, 25031 | |
| Contact: Andriy Gardashnikov 066 081 5334 a_gardashnikov@ukr.net | |
| Principal Investigator: Kostiantyn Volodymyrovych Yarynich, MD | |
| Volyn Regional Oncology Center, Department of Oncochemotherapy | Recruiting |
| Lutsk, Ukraine, 43018 | |
| Contact: Spetruk Sergij 380 332 260769 serg.onko@gmail.com | |
| Principal Investigator: Orest Petrovych Andrusenko | |
| Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy | Recruiting |
| Lviv, Ukraine, 79031 | |
| Contact: Uaroslav Vasyliovych Shparyk 38 0322 23 14 82 yshparyk@ukr.net | |
| Principal Investigator: Oleksyak Olha Oleksiivna, MD | |
| Odesa Regional Clinical Hospital, Center for Mastology | Recruiting |
| Odesa, Ukraine, 65117 | |
| Contact: Batyuk Liliya 38(048)755 8339 odessaunblin@yandex.ua | |
| Principal Investigator: Olkesandr Andriiovych Berzoi, MD | |
Sponsors and Collaborators
Galena Biopharma, Inc.
Investigators
| Principal Investigator: | Elizabeth A Mittendorf, MD,FACS | M.D. Anderson Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Galena Biopharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT01479244 History of Changes |
| Other Study ID Numbers: | NeuVax(TM) PH3-01 |
| Study First Received: | November 20, 2011 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Galena Biopharma, Inc.:
|
HER2 low or intermediate breast cancer node-positive tumors |
Additional relevant MeSH terms:
|
Breast Neoplasms Recurrence Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013