Breast Cancer With Low to Intermediate HER2 Expression Clinical Trial
— PRESENTOfficial title:
PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment
| Verified date | February 2017 |
| Source | Galena Biopharma, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 758 |
| Est. completion date | September 21, 2016 |
| Est. primary completion date | September 21, 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Central Onco Hospital | Plovdiv | |
| Bulgaria | Serdika | Sofia | |
| Bulgaria | Tsaritsa Yoanna - ISUL | Sofia | |
| Bulgaria | Complex Oncology Center, Veliko Tarnovo | Tarnovo | |
| Bulgaria | Sveta Marina | Varna | |
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | Hospital Charles LeMorne | Greenfield Park | Quebec |
| Canada | Ottawa Hospital Cancer Centre | Ottawa | Ontario |
| Canada | Health Sciences North Cancer Centre | Sudbury | Ontario |
| Canada | Sunnybrook Research Institute | Toronto | Ontario |
| Czech Republic | Masaryk Memorial Cancer Institute, Comprehensive Cancer Care Clinic | Brno | |
| Czech Republic | University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy | Hradec Kralove | |
| Czech Republic | University Hospital Olomouc, Clinic of Oncology | Olomouc | |
| Czech Republic | General University Hospital in Prague, Clinic of Oncology | Prague 2 | |
| France | Institut de Cancérologie de l'Ouest Siet Paul Papin | Angers | Cedex 9 |
| France | Centre Oscar Lambret | Cédex | Lille |
| France | Centre Antoine Lacassagne | Nice | |
| France | Institut de Cancérologie de l'Ouest/René Gauducheau | St Herblain, Nantes Cedex | Loire-Atlantique |
| Germany | Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum | Berlin | |
| Germany | Brustzentrum Klinikum Bremen-Mitte gGmbH | Bremen | |
| Germany | Universitätsklinikum Erlangen, Frauenklinik | Erlangen | |
| Germany | Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Klinik für Senologie/Brustzentrum | Essen | |
| Germany | Universitätsklinikum Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe | Frankfurt | |
| Germany | Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie | Heidelberg | |
| Germany | Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | |
| Germany | Universität Marburg | Marburg | |
| Germany | Rotkreuzklinikum München gGmbH, Frauenklinik | Muenchen | |
| Germany | Universitätsklinikum Münster, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe | Münster | |
| Germany | Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik | Stuttgart | |
| Germany | Klinikum Mutterhaus der Borromaeerinnen | Trier | |
| Germany | Gemeinschaftspraxis für Innere Medizin, Haematologie und internistische Onkologie Dr. R Schlag/Dr. Schoettker | Wuerzburg | |
| Hungary | Semmelweis University, Department of Diagnostic Radiology and Oncotherapy | Budapest | |
| Hungary | Szent Margit Hospital, V. Department of Internal Medicine, Oncology | Budapest | |
| Hungary | Petz Aladar County Teaching Hospital, Center for Oncoradiology | Gyor | |
| Hungary | Kaposi Mor County Teaching Hospital, Center for Clinical Oncology | Kaposvar | |
| Hungary | Borsod-Abauj-Zemplen County Hospital and University Educational Hospital, Center for Clinical Oncology and Radiology | Miskolc | |
| Hungary | Hetenyi Geza Hospital, Department of Oncology | Szolnok | Jasz-Nagykun-Szolnok |
| Israel | Rambam Health Care Campus | Haifa | |
| Israel | Rabin Medical Centre | Petach Tikva | |
| Israel | Kaplan Medical Centre | Rehovot | |
| Israel | Sheba Medical Centre | Tel Hasomer | Ramat Gan |
| Poland | Polish Red Cross Marine Hospital, Department of Chemotherapy | Gdynia | |
| Poland | Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy | Kamienskiego | Wroclaw |
| Poland | Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Chemotheraphy | Lodz | |
| Poland | Greater Poland Cancer Center, Department of Chemotherapy | Poznan | |
| Poland | Magodent | Warsaw | |
| Poland | Non-Public Health Care Facility MAGODENT | Warsaw | |
| Romania | Dr. Constantin Opris County Emergency Hospital, Department of Oncology | Baia Mare, Maramures | |
| Romania | Bucharest Universtiy Emergency Hosptial, Oncology Department | Bucharest | |
| Romania | Coltea Clinical Hospital, Oncology Department | Bucharest | |
| Romania | Filantropia Clinical Hospital, Obstetrics and Gynaecology Department | Bucharest | |
| Romania | "Prof. Dr. Ion Chiricuta" Institute of Oncology | Cluj-Napoca | |
| Romania | Medisprof SRL, Department of Medical Oncology | Cluj-Napoca | Cluj |
| Romania | Oncology Center "Sf. Nectarie", Department of Medical Oncology | Craiova | Dolj County |
| Romania | Iasi Regional Oncology Institute, Department of Medical Oncology | Iasi | |
| Romania | "Gavril Curteanu" Municipal Clinical Hospital | Oradea | Bihor |
| Romania | Oncomed SRL, Department of Medical Oncology | Timisoara | |
| Russian Federation | Arkhangelsk Clinical Oncology Center | Arkhangelsk | |
| Russian Federation | Sverdlovsk Regional Oncology Center | Ekaterinburg | |
| Russian Federation | Regional Oncology Center | Irkutsk | |
| Russian Federation | Ivanovo Regional Oncology Center | Ivanovo | |
| Russian Federation | Republican Clinical Oncoogy Center | Kazan | Republic of Tatarstan |
| Russian Federation | Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration | Krasnodar | |
| Russian Federation | Krasnoyarsk Kryzhanovsky Regional Oncology Center | Krasnoyarsk | |
| Russian Federation | Kursk Regional Clinical Oncology Center | Kursk | |
| Russian Federation | N.N. Blokhin Russian Cancer Research Center | Moscow | |
| Russian Federation | N.N. Blokhin Russian Cancer Reserach Center | Moscow | |
| Russian Federation | Clinical Diagnostics Center | Nizhny Novgorod | |
| Russian Federation | Nizhny Novgorod Regional Oncology Center | Nizhny Novgorod | |
| Russian Federation | Orel Oncology Center | Orel | |
| Russian Federation | Orenburg Regional Clinical Oncology Center | Orenburg | |
| Russian Federation | Pyatigorsk Oncology Center | Pyatigorsk | Stavropol Region |
| Russian Federation | Medical Institution of Ryazan Region | Ryazan | |
| Russian Federation | Samara Regional Clinical Oncology Center | Samara | |
| Russian Federation | Republican Oncology Center | Saransk | Republic of Mordovia |
| Russian Federation | Oncology Center #2, Department of Healthcare of Krasnodar Territory Administration | Sochi | Krasnodar |
| Russian Federation | Petrov Research Institute of Oncology | St Petersburg | |
| Russian Federation | Leningrad Regional Oncology Center | St. Petersburg | |
| Russian Federation | Mechnikov North-Western State Medical University | St. Petersburg | |
| Russian Federation | Municipal Clinical Oncology Center | St. Petersburg | |
| Russian Federation | St. Petersburg Clinical Hospital | St. Petersburg | |
| Russian Federation | Tambov Regional Clinical Oncology Center | Tambov | |
| Russian Federation | Research Institute of Oncology | Tomsk | |
| Russian Federation | Bashkir State Medical University | Ufa | |
| Russian Federation | Regional Clinical Oncology Center | Veliky Novgorod | |
| Russian Federation | Volgograd Regional Oncology Center #3 | Volzhskiy | |
| Russian Federation | Yaroslavl Regional Oncology Center | Yaroslavl | |
| Ukraine | Chernivtsi Regional Clinical Oncology Center, Day Care Unit | Chernivtsi | |
| Ukraine | Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy | Dnipropetrovsk | |
| Ukraine | Donetsk City Oncology Center | Donetsk | |
| Ukraine | Donetsk Regional Antitumor Center, Oncosurgery Department #2 | Donetsk | |
| Ukraine | Kharkiv Regional Clinical Oncology Center, Day Care Unit | Kharkiv | Kyivskyi District |
| Ukraine | State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine | Kharkiv | |
| Ukraine | Public Institution: Kiev Regional Oncology Hospital within Kyiv Regional Council | Kiev | |
| Ukraine | Kirovohrad Regional Oncology Center, Department of Mammology | Kirovohrad | |
| Ukraine | Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy | Kryvyi Rih | Dnipropetrovsk Region |
| Ukraine | Kyiv City Clinical Oncology Center, Department of Chemotherapy | Kyiv | |
| Ukraine | Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy | Lviv | |
| Ukraine | Mariupol City Interdistrict Oncology Center, Surgery Department #2 | Mariupol | Donetsk Region |
| Ukraine | Odesa Regional Clinical Hospital, Center for Mastology | Odesa | |
| Ukraine | Clinical Diagnostics Center | Simferopol | Autonomous Republic of Crimea |
| Ukraine | Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy | Uzhhorod | |
| Ukraine | Vinnytsia Regional Clinical Oncology Center | Vinnytsia | |
| Ukraine | Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council | Zaporizhia | |
| United Kingdom | Leeds Teaching Hospitals Trust, St. James University Hospital | Leeds | West Yorkshire |
| United Kingdom | Leicester Royal Infirmary | Leicester | |
| United Kingdom | The Royal Marsden NHS Foundation Trust | London | |
| United Kingdom | Macclesfield District General Hospital | Macclesfield | Cheshire |
| United Kingdom | James Cook University Hospital | Middlesborough | |
| United Kingdom | Academic Unit of Oncology, Nottingham University Hospital-City Campus | Nottingham | |
| United Kingdom | Plymouth Oncology Centre, Derriford Hospital | Plymouth | |
| United Kingdom | Weston Park Hospital | Sheffield | |
| United Kingdom | Southampton General Hospital | Southampton | |
| United Kingdom | University Hospital of North Staffordshire | Stoke on Trent | |
| United Kingdom | The Royal Marsden NHS Foundation Trust | Sutton | Surrey |
| United Kingdom | The Christie NHS Foundation Trust | Withington | Manchester |
| United States | Akron General Medical Center | Akron | Ohio |
| United States | Northeast Georgia Cancer Care | Athens | Georgia |
| United States | Interventional Spine and Pain Management | Atlanta | Georgia |
| United States | University of Colorado Cancer Center, Anschutz Medical Campus | Aurora | Colorado |
| United States | Innovative Medical Research of South Florida, Inc. | Aventura | Florida |
| United States | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana |
| United States | Physiatry Consultants | Bay City | Michigan |
| United States | Alabama Oncology | Bessemer | Alabama |
| United States | Center of Cancer and Blood Disorders (VEEDA network) | Bethesda | Maryland |
| United States | St. Alexius Medical Center, Mid Dakota Clinic, PC | Bismarck | North Dakota |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Eastchester Cancer Care Center | Bronx | New York |
| United States | Michigan Interventional Pain Center | Brownstown | Michigan |
| United States | East Valley Hematology and Oncology Medical Group | Burbank | California |
| United States | Lahey Clinic Department of Hematology and Oncology | Burlington | Massachusetts |
| United States | Coastal Pain Research | Carlsbad | California |
| United States | Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center | Chicago | Illinois |
| United States | PRIDE | Dallas | Texas |
| United States | UT Southwestern Medical Center / Simmons Comprehensive Cancer Center | Dallas | Texas |
| United States | Western Connecticut Health Network, Danbury Hospital | Danbury | Connecticut |
| United States | Navajo Road Pain Management Center | El Cajon | California |
| United States | Virginia Cancer Specialists | Fairfax | Virginia |
| United States | Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center | Fort Lauderdale | Florida |
| United States | California Cancer Associates For Research and Excellence | Fresno | California |
| United States | California Cancer Associates for Research and Excellence, Inc. | Fresno | California |
| United States | Brooke Army Medical Center (now SAMMC) | Ft. Sam Houston | Texas |
| United States | St. Jude Medical Center, Virginia K. Crosson Cancer Center | Fullerton | California |
| United States | The West Clinic Comprehensive Breast Center | Germantown | Tennessee |
| United States | Gettysburg Cancer Center | Gettysburgh | Pennsylvania |
| United States | Red Rocks Center for Rehabilitation | Golden | Colorado |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Interventional Pain Management | Irvine | California |
| United States | Cancer Specialists of North Florida (ICON) | Jacksonville | Florida |
| United States | Conemaugh Memorial Hospital-Memorial Medical Center | Johnstown | Pennsylvania |
| United States | South Orange County Surgical Medical Group | Laguna Hills | California |
| United States | Alexander Ford, MD | Los Angeles | California |
| United States | Cancer Care Institute | Los Angeles | California |
| United States | Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California |
| United States | Pete J. Ruane, MD, Inc. | Los Angeles | California |
| United States | University of Southern California/Norris Cancer Hospital | Los Angeles | California |
| United States | James Graham Brown Cancer Center, University of Louisville | Louisville | Kentucky |
| United States | Central Georgia Cancer Care | Macon | Georgia |
| United States | The West Clinic | Memphis | Tennessee |
| United States | Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center | Milwaukee | Wisconsin |
| United States | Physicians Pain Specialists of Alabama, P.C. | Mobile | Alabama |
| United States | J. Fred Stoner, MD | New Castle | Pennsylvania |
| United States | Fountain Medical Group | New York | New York |
| United States | Upper East Side Pain Medicine, P.C. | New York | New York |
| United States | Weill Cornell Medical College | New York | New York |
| United States | Cancer Treatment Centers of America | Newnan | Georgia |
| United States | MD Anderson Center-Orlando Health | Orlando | Florida |
| United States | Pain Management Institute | Overland Park | Kansas |
| United States | Pain Centers Nationwide | Peoria | Arizona |
| United States | University of Pittsburgh Medical Center (UPMC) Cancer Center | Pittsburgh | Pennsylvania |
| United States | Florida Cancer Care | Plantation | Florida |
| United States | Florida Cancer Research Institute (Florida Cancer Care) | Plantation | Florida |
| United States | OHSU Knight Cancer Institute | Portland | Oregon |
| United States | Jerrold Rosenberg, MD | Providence | Rhode Island |
| United States | William Beaumont Hospital Cancer Center | Royal Oak | Michigan |
| United States | Glenn Saperstein, D.O., LLC | Saginaw | Michigan |
| United States | Cancer Care Centers of South Texas | San Antonio | Texas |
| United States | Clinical Trials of Texas, Inc | San Antonio | Texas |
| United States | Moores UC San Diego Cancer Center (UCSD) | San Diego | California |
| United States | University of California, San Francisco (UCSF), Hellen Diller Family Comprehensive Cancer Center | San Francisco | California |
| United States | Pain Institute of Santa Monica | Santa Monica | California |
| United States | Valley Pain Consultants | Scottsdale | Arizona |
| United States | Swedish Cancer Institute Research | Seattle | Washington |
| United States | Advanced Physical Medicine | St. Clair Shores | Michigan |
| United States | Pain Management Associates of CT, PC | Stamford | Connecticut |
| United States | Stamford Hospital, Bennett Cancer Center | Stamford | Connecticut |
| United States | Comprehensive Pain Management | Syosset | New York |
| United States | Multicare Health System-Research Institute | Tacoma | Washington |
| United States | H.Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
| United States | Cancer Treatment Centers of America | Tulsa | Oklahoma |
| United States | Cancer Center of Kansas | Wichita | Kansas |
| United States | APWI | Williamsville | New York |
| United States | Progressive Pain Solutions | Wind Gap | Pennsylvania |
| United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
| United States | Randy Scharlach, MD | Woodland Hills | California |
| Lead Sponsor | Collaborator |
|---|---|
| Galena Biopharma, Inc. |
United States, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Israel, Poland, Romania, Russian Federation, Ukraine, United Kingdom,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparison of DFS in vaccine treated patients and control patients | 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. | 36 months | |
| Secondary | Assessment of DFS and OS at 3, 5 and 10 years in vaccine and control groups, respectively; assessment of safety | 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) |
3 through 10 years |