RECRUITING Phase 3 ClinicalTrials.gov

ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer

Sponsor: BioNTech SE • ClinicalTrials.gov ID: NCT07173751

Registry updated: 2026-10-20

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Description

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.

Interventions

Pumitamig (Drug)
Solution for intravenous (IV) infusion
Nab-paclitaxel/Paclitaxel (Drug)
IV infusion
Gemcitabine (Drug)
IV infusion
Carboplatin (Drug)
IV infusion
Eribulin (Drug)
IV infusion
Matching placebo (Drug)
IV infusion

Eligibility criteria

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.

Conditions

Breast Neoplasms

Locations

Highlands Oncology Group — Springdale, Arkansas, United States
University Of California - San Diego Moores Cancer Center — La Jolla, California, United States
Cancer and Blood Specialty Clinic (CBSC) — Los Alamitos, California, United States
Cedar Sinai - Samuel Oschin Cancer Center — Los Angeles, California, United States
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center — Palo Alto, California, United States
University Of California Davis Health System — Sacramento, California, United States
Sansum Clinic — Santa Barbara, California, United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI) — Santa Monica, California, United States
Florida Cancer Specialists — Fort Myers, Florida, United States
Cancer Care Centers of Brevard, Inc — Palm Bay, Florida, United States
Sacred Heart Medical Oncology Group — Pensacola, Florida, United States
Florida Cancer Specialists North — St. Petersburg, Florida, United States
Cancer Care Specialists — Decatur, Illinois, United States
Cancer Care Specialists of Illinois — O'Fallon, Illinois, United States
Carle Foundation Hospital d/b/a Carle Cancer Center — Urbana, Illinois, United States
University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center — Louisville, Kentucky, United States
New England Cancer Specialists — Westbrook, Maine, United States
Saint Agnes Hospital, Clinical Research Center — Baltimore, Maryland, United States
Maryland Oncology Hematology P.A. — Columbia, Maryland, United States
Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
Karmanos Cancer Center — Detroit, Michigan, United States
Profound Research LLC at Michigan Hematology and Oncology Consultants — Royal Oak, Michigan, United States
Healthpartners Regions Specialty Clinics — Saint Louis Park, Minnesota, United States
Healthpartners Regions Specialty Clinics — Saint Paul, Minnesota, United States
Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialist — Grand Island, Nebraska, United States
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha, Nebraska, United States
Summit Medical Group PA — Florham Park, New Jersey, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) — Livingston, New Jersey, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) — Long Branch, New Jersey, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) — New Brunswick, New Jersey, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) — Newark, New Jersey, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) — Somerville, New Jersey, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) — Toms River, New Jersey, United States
Paradigm New York Cancer and Blood Specialists — Bay Shore, New York, United States
Paradigm New York Cancer and Blood Specialists — New York, New York, United States
Paradigm New York Cancer and Blood Specialists — New York, New York, United States
Paradigm New York Cancer and Blood Specialists — New York, New York, United States
Paradigm New York Cancer and Blood Specialists — New York, New York, United States
Paradigm New York Cancer and Blood Specialists — New York, New York, United States
Paradigm New York Cancer and Blood Specialists — New York, New York, United States
Paradigm New York Cancer and Blood Specialists — New York, New York, United States
Paradigm New York Cancer and Blood Specialists — New York, New York, United States
Rochester General Hospital Lipson Cancer Institute — Rochester, New York, United States
Stony Brook University Medical Center — Stony Brook, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Oncology Specialists of Charlotte Pa — Charlotte, North Carolina, United States
Carolina Oncology Specialists — Charlotte, North Carolina, United States
St Charles Bend Cancer Center — Bend, Oregon, United States
Providence Portland Medical Center — Portland, Oregon, United States
St. Charles Cancer Center - Redmond — Redmond, Oregon, United States
Oregon Oncology Specialists — Salem, Oregon, United States
The West Clinic, P.C. dba West Cancer Center — Germantown, Tennessee, United States
Tennessee Oncology — Nashville, Tennessee, United States
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) — Arlington, Texas, United States
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) — Burleson, Texas, United States
UT Southwestern Medical Center at Redbird — Dallas, Texas, United States
University Of Texas Southwestern Medical Center — Dallas, Texas, United States
JPS Health Network - Trinity Springs Pavilion — Fort Worth, Texas, United States
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) — Fort Worth, Texas, United States
UT Southwestern Moncrief Cancer Institute — Fort Worth, Texas, United States
Oncology Consultants PA — Houston, Texas, United States
Oncology Consultants PA — Houston, Texas, United States
UT Southwestern Medical Center at Richardson/Plano — Richardson, Texas, United States
Renovatio Clinical - The Woodlands Research Center — The Woodlands, Texas, United States
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) — Weatherford, Texas, United States
Bon Secours Cancer Institute at Memorial Regional — Mechanicsville, Virginia, United States
Bon Secours St. Francis Medical Center — Midlothian, Virginia, United States
Bon Secours Cancer Institute at St. Mary's — Richmond, Virginia, United States
Northwest Medical Specialties, PLLC — Tacoma, Washington, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Hospital Aleman — Buenos Aires, Argentina
Centro Medico Austral — Buenos Aires, Argentina
Clinica Adventista Belgrano (CAB) — Caba, Argentina
Breast Clínica de la Mama — La Plata, Argentina
Sanatorio de La Mujer — Rosario, Argentina
Centro Oncologico de Excelencia (COE) — San Juan, Argentina
Exelsus SRL — San Miguel de Tucumán, Argentina
Centro de Investigaciones Clinicas. Clinica Viedma S. A — Viedma, Argentina
St Vincent's Hospital - The Kinghorn Cancer Centre — Darlinghurst, New South Wales, Australia
GenesisCare St Andrew's Precinct — Adelaide, South Australia, Australia
Peninsula & South Eastern Hematology and Oncology Group — Frankston, Victoria, Australia
Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
Monash University - Monash Medical Centre (MMC) - Clayton — Melbourne, Victoria, 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
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner — Curitiba, Brazil
Associacao de Combate ao Cancer em Goias Hospital Araujo Jorge — Goiânia, Brazil
Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks) — Pelotas, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) — Porto Alegre, Brazil
Centro de Quimioterapia — Porto Alegre, Brazil
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS — Porto Alegre, Brazil
Perola Centro de Pesquisa em Oncologia — São Paulo, Brazil
Hospital Alemao Oswaldo Cruz (HAOC) — São Paulo, Brazil
Hospital Santa Marcelina — São Paulo, Brazil
Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita — Vitória, Brazil
Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital Fleurimont — Québec, Canada
Sunnybrook Research Unit-Cognitive Neurology Research Unit in the Hurvitz Brain Science Research Program — Toronto, Canada
Changde First People's Hospital — Changde, China
Affiliated Cancer Hospital of Harbin Medical University — Harbin, China
The First Affiliated Hospital of USTC (Anhui Provincial Hospital) — Hefei, China
Shandong Cancer Hospital And Institute — Jinan, China
The First Hospital of Lanzhou University — Lanzhou, China
Linyi Cancer Hospital — Linyi, China
Nanchang People's Hospital — Nanchang, China
Jiangsu Peoples Hospital — Nanjing, China
The Second Peoples Hospital of Neijiang — Neijiang, China
Fudan University - Shanghai Cancer Center (FUSCC) — Shanghai, China
Shanxi Provincial Tumor Hospital (Shanxi Oncology Hospital) — Taiyuan, China
Zhongnan Hospital of Wuhan University — Wuhan, China
Xi'an International Medical Center Hospital — Xi'an, China
The Central Hospital of Yongzhou - North Campus — Yongzhou, China
The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China
Fakultni Nemocnice Ostrava — Nový Jičín, Czechia
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
Universitätsklinikum Frankfurt — Frankfurt, 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
Universitätsmedizin Mannheim GmbH — Mannheim, 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
Azienda Ospedaliera Universitaria Pisana — Pisa, Italy
Fondazione Policlinico Universitario Campus Bio-Medico — Roma, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I — Torrette, Italy
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital — Bunkyō City, Japan
Chiba Cancer Center — Chiba, Japan
Fukushima Medical University Hospital — Fukushima, Japan
Gifu University Hospital — Gifu, Japan
Saitama Medical University International Medical Center — Hidaka, Japan
Hiroshima City Hiroshima Citizens Hospital — Hiroshima, Japan
Hakuaikai Medical Corporation Sagara Hospital — Kagoshima, Japan
The Cancer Institute Hospital of JFCR — Kōtoku, Japan
Kumamoto University Hospital — Kumamoto, Japan
Kyoto University Hospital — Kyoto, Japan
National Hospital Organization Shikoku Cancer Center — Matsuyama, Japan
Shizuoka Cancer Center — Nagaizumi-chō, Japan
Nagoya City University Hospital — Nagoya, Japan
Osaka International Cancer Institute — Osaka, Japan
Kindai University Hospital — Sakai, Japan
Tohoku University Hospital — Sendai, Japan
National Center For Global Health And Medicine — Shinjuku-Ku, Japan
Mie University Graduate School Of Medicine — Tsu, Japan
Centro de Investigacion Oncologica Galeias — Aguascalientes, Mexico
Centro De Atencion Oncologica Viva — Mexico City, Mexico
Onco Pall Advance Care Oncology Center Sa de CV — Monterrey, Mexico
Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV — Zapopan, Mexico
Maastricht University Medical Center (MUMC) — Maastricht, Netherlands
Haga Ziekenhuis, Locatie Leyweg — The Hague, Netherlands
Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie — Krakow, Poland
Instytut MSF Sp. z o.o. — Lodz, Poland
IP Clinic Sp. z o.o. — Lodz, Poland
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli — Lublin, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Poland
Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy Instytut Badawczy — Warsaw, Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy — Warsaw, Poland
LUX MED Onkologia Szpital Szamocka — Warsaw, Poland
National Cancer Centre Singapore — Singapore, Singapore
Tan Tock Seng Hospital — Singapore, Singapore
Curie Oncology — Singapore, Singapore
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

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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