New hope for Hard-to-Treat breast cancer: BNT327 combo enters phase 3 trial
NCT ID NCT07173751
First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 6 times
Summary
This phase 3 trial tests whether adding the experimental drug BNT327 to standard chemotherapy helps people with advanced triple-negative breast cancer (TNBC) live longer without their cancer growing. Participants have TNBC that cannot be treated with current PD(L)1 immunotherapies. About 558 volunteers will be randomly assigned to receive either BNT327 plus chemo or a placebo plus chemo. Neither they nor their doctors will know which group they are in. The study measures how long it takes for the cancer to progress and overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BNT327 (also called pumitamig) combined with chemotherapy drugs (nab-paclitaxel, paclitaxel, gemcitabine, carboplatin, or eribulin)
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced triple-negative breast cancer who cannot receive standard immunotherapy, potentially slowing cancer growth and extending survival.
- What could go wrong
- This is a large phase 3 trial, but the drug is still experimental. It may not prove more effective than chemotherapy alone, and side effects from the combination could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 558 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status. * Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and/or progesterone receptor \[PgR\]) 1% to 10%, HER2 immunohistochemistry \[IHC\] 0, 1+, or 2+ with fluorescence in situ hybridization \[FISH\] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care. * Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. * Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial). * Eastern cooperative oncology group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Have received any of the following therapies or drugs prior to the initiation of trial: * Have received prior systemic anticancer therapy for advanced disease. * Have received prior treatment with a PD(L)-1/vascular endothelial growth factor (VEGF) bispecific antibody. * Have received systemic corticosteroids (at a dosage greater than 10 milligrams \[mg\]/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens). * Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment. * Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment. * Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo. * Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed. * Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
181 sites in 16 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ASST Monza-Azienda Ospedaliera San Gerardo
RECRUITINGMonza, 20900, Italy
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Ajou University Hospital
RECRUITINGSuwon, 16499, South Korea
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Asan Medical Center (AMC)
RECRUITINGSeoul, 5505, South Korea
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Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
RECRUITINGVitória, 29043-260, Brazil
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Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
RECRUITINGTorrette, 60126, Italy
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Azienda Unità Sanitaria Locale 2 (USL2) Lucca
RECRUITINGLucca, 55100, Italy
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Bon Secours Cancer Institute at Memorial Regional
RECRUITINGMechanicsville, Virginia, 23116, United States
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Bon Secours Cancer Institute at St. Mary's
RECRUITINGRichmond, Virginia, 23226, United States
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Bon Secours St. Francis Medical Center
RECRUITINGMidlothian, Virginia, 23114, United States
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Cancer Care Centers of Brevard, Inc
RECRUITINGPalm Bay, Florida, 32901, United States
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Cancer Care Specialists
RECRUITINGDecatur, Illinois, 62526, United States
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Cancer Care Specialists of Illinois
RECRUITINGO'Fallon, Illinois, 62269, United States
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Cancer and Blood Specialty Clinic (CBSC)
RECRUITINGLos Alamitos, California, 90720-3309, United States
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Carle Foundation Hospital d/b/a Carle Cancer Center
RECRUITINGUrbana, Illinois, 61801, United States
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Carolina Oncology Specialists
RECRUITINGCharlotte, North Carolina, 28210, United States
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Caucasus Medical Centre
RECRUITINGTbilisi, 186, Georgia
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Cedar Sinai - Samuel Oschin Cancer Center
RECRUITINGLos Angeles, California, 90048, United States
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Centro Medico Austral
RECRUITINGBuenos Aires, C1019ABS, Argentina
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Centro de Investigaciones Clinicas. Clinica Viedma S. A
RECRUITINGViedma, R8500JYJ, Argentina
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Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
RECRUITINGPorto Alegre, 90610-000, Brazil
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Centro di Riferimento Oncologico (CRO)
RECRUITINGAviano, 33081, Italy
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Changde First People's Hospital
RECRUITINGChangde, 415003, China
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Chiba Cancer Center
RECRUITINGChiba, 260-8717, Japan
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Chungbuk National University Hospital
RECRUITINGCheongju-si, 28644, South Korea
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Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
RECRUITINGOxford, OX3 7LE, United Kingdom
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Clinica Adventista Belgrano (CAB)
RECRUITINGCaba, C1430EGF, Argentina
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Edinburgh Cancer Centre-Western General Hospital
RECRUITINGEdinburgh, EH4 2LF, United Kingdom
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Exelsus SRL
RECRUITINGSan Miguel de Tucumán, T4000IAM, Argentina
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Fakultni Thomayerova nemocnice
RECRUITINGPrague, 140 59, Czechia
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Fakultni nemocnice Motol a Homolka
RECRUITINGPrague, 150 06, Czechia
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Florida Cancer Specialists
RECRUITINGFort Myers, Florida, 33916, United States
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Florida Cancer Specialists North
RECRUITINGSt. Petersburg, Florida, 33701, United States
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Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITINGMilan, 20133, Italy
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Fondazione Policlinico Universitario Campus Bio-Medico
RECRUITINGRoma, 00128, Italy
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Fudan University - Shanghai Cancer Center (FUSCC)
RECRUITINGShanghai, 200032, China
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Fukushima Medical University Hospital
RECRUITINGFukushima, 960-1295, Japan
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Fundación Instituto Valenciano de Oncología
RECRUITINGValencia, 46009, Spain
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GenesisCare St Andrew's Precinct
RECRUITINGAdelaide, South Australia, 50000, Australia
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Gifu University Hospital
RECRUITINGGifu, 501-1112, Japan
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Grand hospital de Charleroi
RECRUITINGGilly, 6060, Belgium
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Hakuaikai Medical Corporation Sagara Hospital
RECRUITINGKagoshima, 892-0833, Japan
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Healthpartners Regions Specialty Clinics
RECRUITINGSaint Louis Park, Minnesota, 55426, United States
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Healthpartners Regions Specialty Clinics
RECRUITINGSaint Paul, Minnesota, 55101-2502, United States
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High Technology Hospital Medcenter LTD
RECRUITINGBatumi, 6000, Georgia
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Highlands Oncology Group
RECRUITINGSpringdale, Arkansas, 72762, United States
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Hiroshima City Hiroshima Citizens Hospital
RECRUITINGHiroshima, 730-8518, Japan
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Hospital General Universitario Morales Meseguer
RECRUITINGMurcia, 30008, Spain
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Hospital Universitari Parc Tauli
RECRUITINGSabadell, 8208, Spain
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Hospital Universitario Fundación Jiménez Díaz
RECRUITINGMadrid, 28040, Spain
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Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
RECRUITINGMadrid, 28050, Spain
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Hospital Universitario Reina Sofia
RECRUITINGCórdoba, 14004, Spain
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Hospital Universitario Virgen De La Arrixaca (Huva)
RECRUITINGMurcia, 30120, Spain
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Hospital Universitario de Badajoz
RECRUITINGBadajoz, 6006, Spain
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Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
RECRUITINGCottingham, HU16 5JQ, United Kingdom
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Hämatologische-Onkologische Praxis Augsburg
RECRUITINGAugsburg, 86150, Germany
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IOB Institute of Oncology - Beata Maria Ana Hospital
RECRUITINGMadrid, 28007, Spain
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IP Clinic Sp. z o.o.
RECRUITINGLodz, 90-752, Poland
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IRCCS-Istituto Europeo di Oncologia
RECRUITINGMilan, 20141, Italy
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Imeldaziekenhuis
RECRUITINGBonheiden, 2820, Belgium
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Impar Servicos Hospitalares S/A - Hospital Brasilia
RECRUITINGBrasília, 71681-603, Brazil
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Institut Oncologic Rosell - Hospital General De Catalunya
RECRUITINGBarcelona, 8195, Spain
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Institut fuer Versorgungsforschung in der Onkologie
RECRUITINGKoblenz, 56068, Germany
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Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
RECRUITINGMilan, 20132, Italy
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JPS Health Network - Trinity Springs Pavilion
RECRUITINGFort Worth, Texas, 76104, United States
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Jiangsu Peoples Hospital
RECRUITINGNanjing, 210029, China
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KOC Pardubickeho kraje Multiscan-Pardubicka nemocnice
RECRUITINGPardubice, 530 03, Czechia
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Karmanos Cancer Center
RECRUITINGDetroit, Michigan, 48201, United States
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Kindai University Hospital
RECRUITINGSakai, 590-0197, Japan
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Klinikum Nürnberg Nord
RECRUITINGNuremberg, 90419, Germany
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Korea University Anam Hospital
RECRUITINGSeoul, 2841, South Korea
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Kumamoto University Hospital
RECRUITINGKumamoto, 860-8556, Japan
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Kyoto University Hospital
RECRUITINGKyoto, 606-8507, Japan
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LLC Todua Clinic
RECRUITINGTbilisi, 112, Georgia
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LUX MED Onkologia Szpital Szamocka
RECRUITINGWarsaw, 1748, Poland
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Lahey Hospital & Medical Center
RECRUITINGBurlington, Massachusetts, 01805, United States
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Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
RECRUITINGCuritiba, 81520-060, Brazil
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Linyi Cancer Hospital
RECRUITINGLinyi, 276001, China
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Mammazentrum Hamburg - Brustklinik am Krankenhaus Jerusalem
RECRUITINGHamburg, 20357, Germany
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Maryland Oncology Hematology P.A.
RECRUITINGColumbia, Maryland, 21044, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Monash University - Monash Medical Centre (MMC) - Clayton
RECRUITINGMelbourne, Victoria, 3168, Australia
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Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10461, United States
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Multiprofile Clinic Consilium Medulla
RECRUITINGTbilisi, 0168, Georgia
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Nagoya City University Hospital
RECRUITINGNagoya, 467-8602, Japan
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Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy Instytut Badawczy
RECRUITINGWarsaw, 02-781, Poland
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National Cancer Center
RECRUITINGGoyang-si, 10408, South Korea
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National Cancer Centre Singapore
RECRUITINGSingapore, 168583, Singapore
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National Center For Global Health And Medicine
RECRUITINGShinjuku-Ku, 162-8655, Japan
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National Hospital Organization Shikoku Cancer Center
RECRUITINGMatsuyama, 791-0280, Japan
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New Cross Hospital - The Royal Wolverhampton NHS Trust
RECRUITINGWolverhampton, WV10 0QP, United Kingdom
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New England Cancer Specialists
RECRUITINGWestbrook, Maine, 04092, United States
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North Wales Cancer Treatment C - Glan Clwyd Hospital
RECRUITINGRhyl, LL18 5UJ, United Kingdom
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Northwest Medical Specialties, PLLC
RECRUITINGTacoma, Washington, 98405, United States
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Oncology Consultants PA
RECRUITINGHouston, Texas, 77024, United States
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Oncology Consultants PA
RECRUITINGHouston, Texas, 77030, United States
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Oncology Hematology West, PC dba Nebraska Cancer Specialist
RECRUITINGGrand Island, Nebraska, 68803, United States
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Oncology Specialists of Charlotte Pa
RECRUITINGCharlotte, North Carolina, 28204, United States
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OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
RECRUITINGArlington, Texas, 76104, United States
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OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
RECRUITINGBurleson, Texas, 76028, United States
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OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
RECRUITINGFort Worth, Texas, 76104, United States
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OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
RECRUITINGWeatherford, Texas, 76068, United States
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Onkologisch-Haematologische Schwerpunktpraxis
RECRUITINGBremen, 28209, Germany
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Oregon Oncology Specialists
RECRUITINGSalem, Oregon, 97301, United States
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Paradigm New York Cancer and Blood Specialists
RECRUITINGBay Shore, New York, 11706, United States
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Paradigm New York Cancer and Blood Specialists
RECRUITINGNew York, New York, 10028, United States
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Paradigm New York Cancer and Blood Specialists
RECRUITINGNew York, New York, 10469, United States
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Paradigm New York Cancer and Blood Specialists
RECRUITINGNew York, New York, 11042, United States
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Paradigm New York Cancer and Blood Specialists
RECRUITINGNew York, New York, 11210, United States
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Paradigm New York Cancer and Blood Specialists
RECRUITINGNew York, New York, 11702, United States
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Paradigm New York Cancer and Blood Specialists
RECRUITINGNew York, New York, 11772, United States
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Paradigm New York Cancer and Blood Specialists
RECRUITINGNew York, New York, 11776, United States
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Paradigm New York Cancer and Blood Specialists
RECRUITINGNew York, New York, 11901, United States
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Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists
RECRUITINGOmaha, Nebraska, 68310, United States
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Parc de Salut Mar - Hospital del Mar
RECRUITINGBarcelona, 8003, Spain
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Peninsula & South Eastern Hematology and Oncology Group
RECRUITINGFrankston, Victoria, 3199, Australia
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Perola Centro de Pesquisa em Oncologia
RECRUITINGSão Paulo, 01317-001, Brazil
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Peter MacCallum Cancer Centre
RECRUITINGMelbourne, Victoria, 3000, Australia
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Praxis Fuer Interdisziplinaere Onkologie & Haematologie
RECRUITINGFreiburg im Breisgau, 79106, Germany
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Profound Research LLC at Michigan Hematology and Oncology Consultants
RECRUITINGRoyal Oak, Michigan, 48073, United States
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Providence Portland Medical Center
RECRUITINGPortland, Oregon, 97213, United States
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Renovatio Clinical - The Woodlands Research Center
RECRUITINGThe Woodlands, Texas, 77380, United States
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Rochester General Hospital Lipson Cancer Institute
RECRUITINGRochester, New York, 14621, United States
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Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
RECRUITINGStoke-on-Trent, ST4 6QG, United Kingdom
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Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
RECRUITINGBrighton, BN2 5BE, United Kingdom
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Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITINGLivingston, New Jersey, 07039, United States
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Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITINGLong Branch, New Jersey, 07740, United States
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Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITINGNew Brunswick, New Jersey, 08901, United States
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Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITINGNewark, New Jersey, 07112, United States
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Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITINGSomerville, New Jersey, 08876, United States
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Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITINGToms River, New Jersey, 08755, United States
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SRH Wald-Kliniken Gera GmbH
RECRUITINGGera, 07548, Germany
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Sacred Heart Medical Oncology Group
RECRUITINGPensacola, Florida, 32504, United States
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Saint Agnes Hospital, Clinical Research Center
RECRUITINGBaltimore, Maryland, 21229, United States
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Saint John's Health Center - John Wayne Cancer Institute (JWCI)
RECRUITINGSanta Monica, California, 90404-2312, United States
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Saint Luke's Hospital of Kansas City
RECRUITINGKansas City, Missouri, 64111, United States
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Saitama Medical University International Medical Center
RECRUITINGHidaka, 350-1298, Japan
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Samsung Medical Center
RECRUITINGSeoul, 6351, South Korea
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Sarah Cannon Research Institute
RECRUITINGLondon, W1G 6AD, United Kingdom
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Seoul National University Bundang Hospital (SNUBH)
RECRUITINGSeongnam-si, 13620, South Korea
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Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, 3722, South Korea
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Shandong Cancer Hospital And Institute
RECRUITINGJinan, 250117, China
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Soon Chun Hyang University Cheonan Hospital
RECRUITINGCheonan, 31151, South Korea
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Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
RECRUITINGSouthampton, SO16 6YD, United Kingdom
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St Bartholomew's Hospital - Barts Health NHS Trust
RECRUITINGLondon, EC1A 7BE, United Kingdom
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St Charles Bend Cancer Center
RECRUITINGBend, Oregon, 97701, United States
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St James's University Hospital - Leeds Teaching Hospitals NHS Trust
RECRUITINGLeeds, LS9 7TF, United Kingdom
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St Vincent's Hospital - The Kinghorn Cancer Centre
RECRUITINGDarlinghurst, New South Wales, 2010, Australia
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St. Charles Cancer Center - Redmond
RECRUITINGRedmond, Oregon, 97756, United States
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Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
RECRUITINGPalo Alto, California, 94304-2201, United States
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Stony Brook University Medical Center
RECRUITINGStony Brook, New York, 11794, United States
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Summit Medical Group PA
RECRUITINGFlorham Park, New Jersey, 07932, United States
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Tan Tock Seng Hospital
RECRUITINGSingapore, 308433, Singapore
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Tennessee Oncology
RECRUITINGNashville, Tennessee, 37203, United States
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The Cancer Institute Hospital of JFCR
RECRUITINGKōtoku, 135-8550, Japan
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The Central Hospital of Yongzhou - North Campus
RECRUITINGYongzhou, 425000, China
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The First Affiliated Hospital of Zhengzhou University
RECRUITINGZhengzhou, 450052, China
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The Royal Free Hospital - Royal Free London NHS Foundation Trust
RECRUITINGLondon, NW3 2QG, United Kingdom
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The West Clinic, P.C. dba West Cancer Center
RECRUITINGGermantown, Tennessee, 38002, United States
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Tohoku University Hospital
RECRUITINGSendai, 980-8574, Japan
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Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
RECRUITINGBunkyō City, 113-8677, Japan
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Torbay Hosptial, South Devon Healthcare NHS Foundation Trust
RECRUITINGTorquay, TQ2 7AA, United Kingdom
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UT Southwestern Medical Center at Redbird
RECRUITINGDallas, Texas, 75237, United States
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UT Southwestern Medical Center at Richardson/Plano
RECRUITINGRichardson, Texas, 75080, United States
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UT Southwestern Moncrief Cancer Institute
RECRUITINGFort Worth, Texas, 76104, United States
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Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)
RECRUITINGPelotas, 96020-080, Brazil
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Universidad de Navarra - Clinica Universidad de Navarra (CUN)
RECRUITINGMadrid, 28027, Spain
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Universidad de Navarra - Clínica Universidad de Navarra (CUN)
RECRUITINGPamplona, 31008, Spain
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Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
RECRUITINGBrussels, 1090, Belgium
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Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
RECRUITINGWoluwe-Saint-Lambert, 1200, Belgium
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University College London Hospitals NHS Foundation Trust
RECRUITINGLondon, NW2 1PG, United Kingdom
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University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre
RECRUITINGBristol, BS2 8ED, United Kingdom
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University Hospitals Leuven
RECRUITINGLeuven, 3000, Belgium
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University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center
RECRUITINGLouisville, Kentucky, 40202, United States
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University Of California - San Diego Moores Cancer Center
RECRUITINGLa Jolla, California, 92037, United States
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University Of California Davis Health System
RECRUITINGSacramento, California, 95817-2229, United States
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University Of Texas Southwestern Medical Center
RECRUITINGDallas, Texas, 75390, United States
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Universitätsmedizin Mannheim GmbH
RECRUITINGMannheim, 68167, Germany
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Uniwersyteckie Centrum Kliniczne
RECRUITINGGdansk, 80-214, Poland
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Westmead Hospital
RECRUITINGWestmead, 2145, Australia
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Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
RECRUITINGWarsaw, 04-141, Poland
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Zhongnan Hospital of Wuhan University
RECRUITINGWuhan, 430071, China
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