Clinical trial NCT01479244: Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence
Official title: PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer With Low to Intermediate HER2 Expression
Keywords: HER2
low or intermediate
breast cancer
node-positive tumors
Lead sponsor: Galena Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-24
Enrollment: 758
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This is a multicenter, multinational, prospective, randomized, double-blind, controlled Phase 3 study.

The subjects eligible for this trial have an early stage node-positive breast cancer. Their tumors express low or intermediate levels of the HER2 protein. NeuVax™ will be administered after completion of front-line, standard of care therapy (surgery, radiation therapy, and chemotherapy) and can be given concomitantly with physician prescribed endocrine treatment.

NeuVax™ is the immmunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy through cell lysis HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of DFS, the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study.

The active portion of the study will last three years (36 months). The follow-up will last from 5 to 10 years.

Endpoints:

1. Primary efficacy endpoint:

   * 3-year DFS
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

Primary outcomes:
measure: Comparison of DFS in vaccine treated patients and control patients
timeFrame: 36 months
Secondary outcomes:
measure: Assessment of DFS and OS at 3, 5 and 10 years in vaccine and control groups, respectively; assessment of safety
timeFrame: 3 through 10 years
Other outcomes:
Locations:
city: Bessemer
country: United States
facility: Alabama Oncology
state: Alabama
city: Mobile
country: United States
facility: Physicians Pain Specialists of Alabama, P.C.
state: Alabama
city: Peoria
country: United States
facility: Pain Centers Nationwide
state: Arizona
city: Scottsdale
country: United States
facility: Valley Pain Consultants
state: Arizona
city: Burbank
country: United States
facility: East Valley Hematology and Oncology Medical Group
state: California
city: Carlsbad
country: United States
facility: Coastal Pain Research
state: California
city: El Cajon
country: United States
facility: Navajo Road Pain Management Center
state: California
city: Fresno
country: United States
facility: California Cancer Associates for Research and Excellence, Inc.
state: California
city: Fresno
country: United States
facility: California Cancer Associates For Research and Excellence
state: California
city: Fullerton
country: United States
facility: St. Jude Medical Center, Virginia K. Crosson Cancer Center
state: California
city: Irvine
country: United States
facility: Interventional Pain Management
state: California
city: Laguna Hills
country: United States
facility: South Orange County Surgical Medical Group
state: California
city: Los Angeles
country: United States
facility: University of Southern California/Norris Cancer Hospital
state: California
city: Los Angeles
country: United States
facility: Alexander Ford, MD
state: California
city: Los Angeles
country: United States
facility: Cancer Care Institute
state: California
city: Los Angeles
country: United States
facility: Pete J. Ruane, MD, Inc.
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
state: California
city: San Diego
country: United States
facility: Moores UC San Diego Cancer Center (UCSD)
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF), Hellen Diller Family Comprehensive Cancer Center
state: California
city: Santa Monica
country: United States
facility: Pain Institute of Santa Monica
state: California
city: Woodland Hills
country: United States
facility: Randy Scharlach, MD
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center, Anschutz Medical Campus
state: Colorado
city: Golden
country: United States
facility: Red Rocks Center for Rehabilitation
state: Colorado
city: Danbury
country: United States
facility: Western Connecticut Health Network, Danbury Hospital
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital, Bennett Cancer Center
state: Connecticut
city: Stamford
country: United States
facility: Pain Management Associates of CT, PC
state: Connecticut
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida, Inc.
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida (ICON)
state: Florida
city: Orlando
country: United States
facility: MD Anderson Center-Orlando Health
state: Florida
city: Plantation
country: United States
facility: Florida Cancer Research Institute (Florida Cancer Care)
state: Florida
city: Plantation
country: United States
facility: Florida Cancer Care
state: Florida
city: Tampa
country: United States
facility: H.Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Athens
country: United States
facility: Northeast Georgia Cancer Care
state: Georgia
city: Atlanta
country: United States
facility: Interventional Spine and Pain Management
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care
state: Georgia
city: Newnan
country: United States
facility: Cancer Treatment Centers of America
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center
state: Illinois
city: Overland Park
country: United States
facility: Pain Management Institute
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Louisville
country: United States
facility: James Graham Brown Cancer Center, University of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Bethesda
country: United States
facility: Center of Cancer and Blood Disorders (VEEDA network)
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Department of Hematology and Oncology
state: Massachusetts
city: Bay City
country: United States
facility: Physiatry Consultants
state: Michigan
city: Brownstown
country: United States
facility: Michigan Interventional Pain Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital Cancer Center
state: Michigan
city: Saginaw
country: United States
facility: Glenn Saperstein, D.O., LLC
state: Michigan
city: St. Clair Shores
country: United States
facility: Advanced Physical Medicine
state: Michigan
city: Bronx
country: United States
facility: Eastchester Cancer Care Center
state: New York
city: New York
country: United States
facility: Fountain Medical Group
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Upper East Side Pain Medicine, P.C.
state: New York
city: Syosset
country: United States
facility: Comprehensive Pain Management
state: New York
city: Williamsville
country: United States
facility: APWI
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Bismarck
country: United States
facility: St. Alexius Medical Center, Mid Dakota Clinic, PC
state: North Dakota
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America
state: Oklahoma
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Gettysburgh
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Johnstown
country: United States
facility: Conemaugh Memorial Hospital-Memorial Medical Center
state: Pennsylvania
city: New Castle
country: United States
facility: J. Fred Stoner, MD
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) Cancer Center
state: Pennsylvania
city: Wind Gap
country: United States
facility: Progressive Pain Solutions
state: Pennsylvania
city: Providence
country: United States
facility: Jerrold Rosenberg, MD
state: Rhode Island
city: Germantown
country: United States
facility: The West Clinic Comprehensive Breast Center
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Dallas
country: United States
facility: PRIDE
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center / Simmons Comprehensive Cancer Center
state: Texas
city: Ft. Sam Houston
country: United States
facility: Brooke Army Medical Center (now SAMMC)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute Research
state: Washington
city: Tacoma
country: United States
facility: Multicare Health System-Research Institute
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center
state: Wisconsin
city: Plovdiv
country: Bulgaria
facility: Central Onco Hospital
city: Sofia
country: Bulgaria
facility: Serdika
city: Sofia
country: Bulgaria
facility: Tsaritsa Yoanna - ISUL
city: Tarnovo
country: Bulgaria
facility: Complex Oncology Center, Veliko Tarnovo
city: Varna
country: Bulgaria
facility: Sveta Marina
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Hospital Cancer Centre
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Greenfield Park
country: Canada
facility: Hospital Charles LeMorne
state: Quebec
city: Brno
country: Czech Republic
facility: Masaryk Memorial Cancer Institute, Comprehensive Cancer Care Clinic
city: Hradec Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc, Clinic of Oncology
city: Prague 2
country: Czech Republic
facility: General University Hospital in Prague, Clinic of Oncology
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest Siet Paul Papin
state: Cedex 9
city: Cédex
country: France
facility: Centre Oscar Lambret
state: Lille
city: St Herblain, Nantes Cedex
country: France
facility: Institut de Cancérologie de l'Ouest/René Gauducheau
state: Loire-Atlantique
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Berlin
country: Germany
facility: Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum
city: Bremen
country: Germany
facility: Brustzentrum Klinikum Bremen-Mitte gGmbH
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Frauenklinik
city: Essen
country: Germany
facility: Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Klinik für Senologie/Brustzentrum
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Marburg
country: Germany
facility: Universität Marburg
city: Muenchen
country: Germany
facility: Rotkreuzklinikum München gGmbH, Frauenklinik
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromaeerinnen
city: Wuerzburg
country: Germany
facility: Gemeinschaftspraxis für Innere Medizin, Haematologie und internistische Onkologie Dr. R Schlag/Dr. Schoettker
city: Szolnok
country: Hungary
facility: Hetenyi Geza Hospital, Department of Oncology
state: Jasz-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: Szent Margit Hospital, V. Department of Internal Medicine, Oncology
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Diagnostic Radiology and Oncotherapy
city: Gyor
country: Hungary
facility: Petz Aladar County Teaching Hospital, Center for Oncoradiology
city: Kaposvar
country: Hungary
facility: Kaposi Mor County Teaching Hospital, Center for Clinical Oncology
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen County Hospital and University Educational Hospital, Center for Clinical Oncology and Radiology
city: Tel Hasomer
country: Israel
facility: Sheba Medical Centre
state: Ramat Gan
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petach Tikva
country: Israel
facility: Rabin Medical Centre
city: Rehovot
country: Israel
facility: Kaplan Medical Centre
city: Kamienskiego
country: Poland
facility: Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy
state: Wroclaw
city: Gdynia
country: Poland
facility: Polish Red Cross Marine Hospital, Department of Chemotherapy
city: Lodz
country: Poland
facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Chemotheraphy
city: Poznan
country: Poland
facility: Greater Poland Cancer Center, Department of Chemotherapy
city: Warsaw
country: Poland
facility: Magodent
city: Warsaw
country: Poland
facility: Non-Public Health Care Facility MAGODENT
city: Oradea
country: Romania
facility: "Gavril Curteanu" Municipal Clinical Hospital
state: Bihor
city: Cluj-Napoca
country: Romania
facility: Medisprof SRL, Department of Medical Oncology
state: Cluj
city: Craiova
country: Romania
facility: Oncology Center "Sf. Nectarie", Department of Medical Oncology
state: Dolj County
city: Baia Mare, Maramures
country: Romania
facility: Dr. Constantin Opris County Emergency Hospital, Department of Oncology
city: Bucharest
country: Romania
facility: Filantropia Clinical Hospital, Obstetrics and Gynaecology Department
city: Bucharest
country: Romania
facility: Coltea Clinical Hospital, Oncology Department
city: Bucharest
country: Romania
facility: Bucharest Universtiy Emergency Hosptial, Oncology Department
city: Cluj-Napoca
country: Romania
facility: "Prof. Dr. Ion Chiricuta" Institute of Oncology
city: Iasi
country: Romania
facility: Iasi Regional Oncology Institute, Department of Medical Oncology
city: Timisoara
country: Romania
facility: Oncomed SRL, Department of Medical Oncology
city: Sochi
country: Russian Federation
facility: Oncology Center #2, Department of Healthcare of Krasnodar Territory Administration
state: Krasnodar
city: Saransk
country: Russian Federation
facility: Republican Oncology Center
state: Republic of Mordovia
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncoogy Center
state: Republic of Tatarstan
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Oncology Center
state: Stavropol Region
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncology Center
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Center
city: Irkutsk
country: Russian Federation
facility: Regional Oncology Center
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Center
city: Krasnodar
country: Russian Federation
facility: Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Kryzhanovsky Regional Oncology Center
city: Kursk
country: Russian Federation
facility: Kursk Regional Clinical Oncology Center
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Cancer Research Center
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Cancer Reserach Center
city: Nizhny Novgorod
country: Russian Federation
facility: Clinical Diagnostics Center
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Oncology Center
city: Orel
country: Russian Federation
facility: Orel Oncology Center
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Oncology Center
city: Ryazan
country: Russian Federation
facility: Medical Institution of Ryazan Region
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Oncology Center
city: St Petersburg
country: Russian Federation
facility: Petrov Research Institute of Oncology
city: St. Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Center
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Mechnikov North-Western State Medical University
city: St. Petersburg
country: Russian Federation
facility: Municipal Clinical Oncology Center
city: Tambov
country: Russian Federation
facility: Tambov Regional Clinical Oncology Center
city: Tomsk
country: Russian Federation
facility: Research Institute of Oncology
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University
city: Veliky Novgorod
country: Russian Federation
facility: Regional Clinical Oncology Center
city: Volzhskiy
country: Russian Federation
facility: Volgograd Regional Oncology Center #3
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Oncology Center
city: Simferopol
country: Ukraine
facility: Clinical Diagnostics Center
state: Autonomous Republic of Crimea
city: Kryvyi Rih
country: Ukraine
facility: Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy
state: Dnipropetrovsk Region
city: Mariupol
country: Ukraine
facility: Mariupol City Interdistrict Oncology Center, Surgery Department #2
state: Donetsk Region
city: Kharkiv
country: Ukraine
facility: Kharkiv Regional Clinical Oncology Center, Day Care Unit
state: Kyivskyi District
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Clinical Oncology Center, Day Care Unit
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy
city: Donetsk
country: Ukraine
facility: Donetsk City Oncology Center
city: Donetsk
country: Ukraine
facility: Donetsk Regional Antitumor Center, Oncosurgery Department #2
city: Kharkiv
country: Ukraine
facility: State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine
city: Kiev
country: Ukraine
facility: Public Institution: Kiev Regional Oncology Hospital within Kyiv Regional Council
city: Kirovohrad
country: Ukraine
facility: Kirovohrad Regional Oncology Center, Department of Mammology
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Center, Department of Chemotherapy
city: Lviv
country: Ukraine
facility: Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy
city: Odesa
country: Ukraine
facility: Odesa Regional Clinical Hospital, Center for Mastology
city: Uzhhorod
country: Ukraine
facility: Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Oncology Center
city: Zaporizhia
country: Ukraine
facility: Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
state: Cheshire
city: Withington
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Manchester
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals Trust, St. James University Hospital
state: West Yorkshire
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital
city: Nottingham
country: United Kingdom
facility: Academic Unit of Oncology, Nottingham University Hospital-City Campus
city: Plymouth
country: United Kingdom
facility: Plymouth Oncology Centre, Derriford Hospital
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Stoke on Trent
country: United Kingdom
facility: University Hospital of North Staffordshire
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Elizabeth A Mittendorf, MD,FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amin A, Benavides LC, Holmes JP, Gates JD, Carmichael MG, Hueman MT, Mittendorf EA, Storrer CE, Jama YH, Craig D, Stojadinovic A, Ponniah S, Peoples GE. Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer Immunol Immunother. 2008 Dec;57(12):1817-25. doi: 10.1007/s00262-008-0509-2. Epub 2008 Apr 8.
citation: Mittendorf EA, Clifton GT, Holmes JP, Clive KS, Patil R, Benavides LC, Gates JD, Sears AK, Stojadinovic A, Ponniah S, Peoples GE. Clinical trial results of the HER-2/neu (E75) vaccine to prevent breast cancer recurrence in high-risk patients: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer. 2012 May 15;118(10):2594-602. doi: 10.1002/cncr.26574. Epub 2011 Oct 11.
citation: Mittendorf EA, Lu B, Melisko M, Price Hiller J, Bondarenko I, Brunt AM, Sergii G, Petrakova K, Peoples GE. Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial. Clin Cancer Res. 2019 Jul 15;25(14):4248-4254. doi: 10.1158/1078-0432.CCR-18-2867. Epub 2019 Apr 29.