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ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Sponsor: BioNTech SE
Summary
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.
Official title: A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
558
Start Date
2025-10-30
Completion Date
2030-09
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
Pumitamig
Solution for intravenous (IV) infusion
Nab-paclitaxel/Paclitaxel
IV infusion
Gemcitabine
IV infusion
Carboplatin
IV infusion
Eribulin
IV infusion
Matching placebo
IV infusion
Locations (104)
Highlands Oncology Group
Springdale, Arkansas, United States
University Of California - San Diego Moores Cancer Center
La Jolla, 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
Sacred Heart Medical Oncology Group
Pensacola, 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
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
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
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
Oregon Oncology Specialists
Salem, Oregon, United States
The West Clinic, P.C. dba West Cancer Center
Germantown, Tennessee, United States
Oncology Consultants PA
Houston, Texas, United States
Oncology Consultants PA
Houston, Texas, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
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
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
Changde First People's Hospital
Changde, China
Shandong Cancer Hospital And Institute
Jinan, China
Fudan University - Shanghai Cancer Center (FUSCC)
Shanghai, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
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
Praxis Fuer Interdisziplinaere Onkologie & Haematologie
Freiburg im Breisgau, Germany
Institut fuer Versorgungsforschung in der Onkologie
Koblenz, 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
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
Kumamoto University Hospital
Kumamoto, Japan
Kyoto University Hospital
Kyoto, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan
Nagoya City University Hospital
Nagoya, Japan
Tohoku University Hospital
Sendai, Japan
National Center For Global Health And Medicine
Shinjuku-Ku, Japan
IP Clinic Sp. z o.o.
Lodz, Poland
Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy 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