ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Nie kwalifikujesz się do standardowego leczenia immunoterapią plus chemioterapią ze względu na poziom ekspresji PD-L1 w guzie
- •Masz zaawansowanego raka piersi (miejscowo nieoperacyjnego lub z przerzutami) - type triple-negative lub typ z niskim stężeniem receptora estrogenowego
- •Masz co najmniej jeden widoczny guz do badania (mierzalny w badaniach obrazowych)
- •Dostarczyłeś próbkę tkanki guza (archiwalną lub świeżą) do badań
- •Twój ogólny stan zdrowia pozwala na uczestnictwo w badaniu (skala ECOG 0-1)
✗ Disqualifies
- •Otrzymałeś chemioterapię lub immunoterapię na zaawansowany rak w przeszłości
- •Otrzymałeś wcześniej leczenie lekiem bispecyficznym przeciwko PD(L)1 i VEGF
- •Przyjmujesz wysokie dawki sterydów (powyżej 10 mg predniozonu dziennie) w ciągu ostatnich 7 dni
- •Otrzymałeś szczepienie żywą szczepionką w ostatnich 4 tygodniach
- •Dostawałeś silne antybiotyki dożylnie w ostatnich 2 tygodniach
- •Jesteś w ciąży, karmisz piersią lub planujesz ciążę w ciągu badania i 6 miesięcy po
- •Miałeś dużą operację, uraz lub zabieg dentystyczny w ostatnich 28 dniach
- •Przeszedłeś przeszczep szpiku lub narządu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 25, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (143)
Highlands Oncology Group
Springdale, United States
University Of California - San Diego Moores Cancer Center
La Jolla, United States
Cedar Sinai - Samuel Oschin Cancer Center
Los Angeles, United States
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
Palo Alto, United States
Sacred Heart Medical Oncology Group
Pensacola, United States
Cancer Care Specialists
Decatur, United States
Cancer Care Specialists of Illinois
O'Fallon, United States
Carle Foundation Hospital d/b/a Carle Cancer Center
Urbana, United States
University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center
Louisville, United States
New England Cancer Specialists
Westbrook, United States
Saint Agnes Hospital, Clinical Research Center
Baltimore, United States
Lahey Hospital & Medical Center
Burlington, United States
Karmanos Cancer Center
Detroit, United States
Profound Research LLC at Michigan Hematology and Oncology Consultants
Royal Oak, United States
Saint Luke's Hospital of Kansas City
Kansas City, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialist
Grand Island, United States
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, United States
Summit Medical Group PA
Florham Park, United States
Paradigm New York Cancer and Blood Specialists
Bay Shore, United States
Paradigm New York Cancer and Blood Specialists
New York, United States
Paradigm New York Cancer and Blood Specialists
New York, United States
Paradigm New York Cancer and Blood Specialists
New York, United States
Paradigm New York Cancer and Blood Specialists
New York, United States
Paradigm New York Cancer and Blood Specialists
New York, United States
Paradigm New York Cancer and Blood Specialists
New York, United States
Paradigm New York Cancer and Blood Specialists
New York, United States
Paradigm New York Cancer and Blood Specialists
New York, United States
Rochester General Hospital Lipson Cancer Institute
Rochester, United States
Stony Brook University Medical Center
Stony Brook, United States
Montefiore Medical Center
The Bronx, United States
Oncology Specialists of Charlotte Pa
Charlotte, United States
Carolina Oncology Specialists
Charlotte, United States
St Charles Bend Cancer Center
Bend, United States
St. Charles Cancer Center - Redmond
Redmond, United States
Oregon Oncology Specialists
Salem, United States
The West Clinic, P.C. dba West Cancer Center
Germantown, United States
UT Southwestern Medical Center at Redbird
Dallas, United States
University Of Texas Southwestern Medical Center
Dallas, United States
UT Southwestern Moncrief Cancer Institute
Fort Worth, United States
Oncology Consultants PA
Houston, United States
Oncology Consultants PA
Houston, United States
UT Southwestern Medical Center at Richardson/Plano
Richardson, United States
Bon Secours Cancer Institute at Memorial Regional
Mechanicsville, United States
Bon Secours St. Francis Medical Center
Midlothian, United States
Bon Secours Cancer Institute at St. Mary's
Richmond, United States
Northwest Medical Specialties, PLLC
Tacoma, United States
Medical College of Wisconsin
Milwaukee, United States
St Vincent's Hospital - The Kinghorn Cancer Centre
Darlinghurst, Australia
GenesisCare St Andrew's Precinct
Adelaide, Australia
Peninsula & South Eastern Hematology and Oncology Group
Frankston, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
Monash University - Monash Medical Centre (MMC) - Clayton
Melbourne, Australia
Westmead Hospital
Westmead, Australia
Imeldaziekenhuis
Bonheiden, Belgium
Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
Brussels, Belgium
Grand hospital de Charleroi
Gilly, Belgium
University Hospitals Leuven
Leuven, Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Impar Servicos Hospitalares S/A - Hospital Brasilia
Brasília, Brazil
Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)
Pelotas, Brazil
Perola Centro de Pesquisa em Oncologia
São Paulo, Brazil
Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
Vitória, Brazil
Changde First People's Hospital
Changde, China
Shandong Cancer Hospital And Institute
Jinan, China
Linyi Cancer Hospital
Linyi, China
Jiangsu Peoples Hospital
Nanjing, China
Fudan University - Shanghai Cancer Center (FUSCC)
Shanghai, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
KOC Pardubickeho kraje Multiscan-Pardubicka nemocnice
Pardubice, Czechia
Fakultni Thomayerova nemocnice
Prague, Czechia
Fakultni nemocnice Motol a Homolka
Prague, Czechia
High Technology Hospital Medcenter LTD
Batumi, Georgia
Multiprofile Clinic Consilium Medulla
Tbilisi, Georgia
LLC Todua Clinic
Tbilisi, Georgia
Caucasus Medical Centre
Tbilisi, Georgia
Hämatologische-Onkologische Praxis Augsburg
Augsburg, Germany
Onkologisch-Haematologische Schwerpunktpraxis
Bremen, Germany
Praxis Fuer Interdisziplinaere Onkologie & Haematologie
Freiburg im Breisgau, Germany
SRH Wald-Kliniken Gera GmbH
Gera, Germany
Mammazentrum Hamburg - Brustklinik am Krankenhaus Jerusalem
Hamburg, Germany
Institut fuer Versorgungsforschung in der Onkologie
Koblenz, Germany
Klinikum Nürnberg Nord
Nuremberg, Germany
Centro di Riferimento Oncologico (CRO)
Aviano, Italy
Azienda Unità Sanitaria Locale 2 (USL2) Lucca
Lucca, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
IRCCS-Istituto Europeo di Oncologia
Milan, Italy
ASST Monza-Azienda Ospedaliera San Gerardo
Monza, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
Torrette, Italy
Chiba Cancer Center
Chiba, Japan
Fukushima Medical University Hospital
Fukushima, Japan
Gifu University Hospital
Gifu, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, Japan
Kumamoto University Hospital
Kumamoto, Japan
Kyoto University Hospital
Kyoto, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan
Nagoya City University Hospital
Nagoya, Japan
Kindai University Hospital
Sakai, Japan
Tohoku University Hospital
Sendai, Japan
National Center For Global Health And Medicine
Shinjuku-Ku, Japan
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
IP Clinic Sp. z o.o.
Lodz, Poland
Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Warsaw, Poland
Soon Chun Hyang University Cheonan Hospital
Cheonan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
National Cancer Center
Goyang-si, South Korea
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si, South Korea
Korea University Anam Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center (AMC)
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Hospital Universitario de Badajoz
Badajoz, Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, Spain
Institut Oncologic Rosell - Hospital General De Catalunya
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
IOB Institute of Oncology - Beata Maria Ana Hospital
Madrid, Spain
Universidad de Navarra - Clinica Universidad de Navarra (CUN)
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Hospital Universitario Virgen De La Arrixaca (Huva)
Murcia, Spain
Universidad de Navarra - Clínica Universidad de Navarra (CUN)
Pamplona, Spain
Hospital Universitari Parc Tauli
Sabadell, Spain
Fundación Instituto Valenciano de Oncología
Valencia, Spain
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre
Bristol, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
Cottingham, United Kingdom
Edinburgh Cancer Centre-Western General Hospital
Edinburgh, United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
St Bartholomew's Hospital - Barts Health NHS Trust
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
The Royal Free Hospital - Royal Free London NHS Foundation Trust
London, United Kingdom
Sarah Cannon Research Institute
London, United Kingdom
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
North Wales Cancer Treatment C - Glan Clwyd Hospital
Rhyl, United Kingdom
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
Torbay Hosptial, South Devon Healthcare NHS Foundation Trust
Torquay, United Kingdom
New Cross Hospital - The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom
Trial contact
BioNTech clinical trials patient information
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.