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Recruiting

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

NCT07173751 · BioNTech SE
In plain English

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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
About this study
The study consists of a: 1. Screening period (up to 28 days); 2. Treatment period, during which participants will receive pumitamig or placebo in combination with chemotherapy (until disease progression, the occurrence of intolerable toxicity, withdrawal, death, or trial termination \[whichever comes first\]); 3. Safety follow-up (FU) period (for up to 90 days after administration of the last dose of trial treatment) and survival follow-up (until the participant dies, withdraws consent for survival status follow-up, loss of contact, or sponsor decision, whichever occurs first). Participants will be randomized 1:1 to receive either pumitamig in combination with the treatment of physician's choice (TPC) chemotherapy (Arm 1) or placebo in combination with TPC chemotherapy (Arm 2). Chemotherapy will be administered per standard of care. The randomization will be stratified based on the following factors: * Prior treatment with cancer immunotherapy (yes versus no) * On-trial chemotherapy regimen (paclitaxel/nab-paclitaxel versus gemcitabine plus carboplatin versus eribulin) * Geography (East Asia versus the rest of the world \[ROW\]) * PD-L1 status (combined positive score \[CPS\] less than \[\<\] 1 versus 1 less than or equal to \[\<=\] CPS \<10).
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.
Study design
Enrollment target: 558 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-10-30
Estimated completion: 2030-09
Last updated: 2026-05-22
Interventions
Drug: PumitamigDrug: Nab-paclitaxel/PaclitaxelDrug: GemcitabineDrug: CarboplatinDrug: EribulinDrug: Matching placebo
Primary outcomes
  • Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) (Up to approximately 32 months)
  • Overall Survival (OS) (Up to approximately 49 months)
Sponsor
BioNTech SE · industry
With: Bristol-Myers Squibb
Contacts & investigators
ContactBioNTech clinical trials patient information · contact · patients@biontech.de · +49 6131 9084
InvestigatorBioNTech Responsible Person · study_director, BioNTech SE
All locations (104)
Highlands Oncology GroupRecruiting
Springdale, Arkansas, United States
University Of California - San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
Cedar Sinai - Samuel Oschin Cancer CenterRecruiting
Los Angeles, California, United States
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer CenterRecruiting
Palo Alto, California, United States
Sacred Heart Medical Oncology GroupRecruiting
Pensacola, Florida, United States
Cancer Care SpecialistsRecruiting
Decatur, Illinois, United States
Cancer Care Specialists of IllinoisRecruiting
O'Fallon, Illinois, United States
Carle Foundation Hospital d/b/a Carle Cancer CenterRecruiting
Urbana, Illinois, United States
University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer CenterRecruiting
Louisville, Kentucky, United States
New England Cancer SpecialistsRecruiting
Westbrook, Maine, United States
Saint Agnes Hospital, Clinical Research CenterRecruiting
Baltimore, Maryland, United States
Lahey Hospital & Medical CenterRecruiting
Burlington, Massachusetts, United States
Karmanos Cancer CenterRecruiting
Detroit, Michigan, United States
Profound Research LLC at Michigan Hematology and Oncology ConsultantsRecruiting
Royal Oak, Michigan, United States
Saint Luke's Hospital of Kansas CityRecruiting
Kansas City, Missouri, United States
Oncology Hematology West, PC dba Nebraska Cancer SpecialistRecruiting
Grand Island, Nebraska, United States
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Summit Medical Group PARecruiting
Florham Park, New Jersey, United States
Rochester General Hospital Lipson Cancer InstituteRecruiting
Rochester, New York, United States
Stony Brook University Medical CenterRecruiting
Stony Brook, New York, United States
Montefiore Medical CenterRecruiting
The Bronx, New York, United States
Oregon Oncology SpecialistsRecruiting
Salem, Oregon, United States
The West Clinic, P.C. dba West Cancer CenterRecruiting
Germantown, Tennessee, United States
Oncology Consultants PARecruiting
Houston, Texas, United States
Oncology Consultants PARecruiting
Houston, Texas, United States
Northwest Medical Specialties, PLLCRecruiting
Tacoma, Washington, United States
St Vincent's Hospital - The Kinghorn Cancer CentreRecruiting
Darlinghurst, New South Wales, Australia
GenesisCare St Andrew's PrecinctRecruiting
Adelaide, South Australia, Australia
Peninsula & South Eastern Hematology and Oncology GroupRecruiting
Frankston, Victoria, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Monash University - Monash Medical Centre (MMC) - ClaytonRecruiting
Melbourne, Victoria, Australia
Westmead HospitalRecruiting
Westmead, Australia
Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)Recruiting
Brussels, Belgium
Grand hospital de CharleroiRecruiting
Gilly, Belgium
University Hospitals LeuvenRecruiting
Leuven, Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-LucRecruiting
Woluwe-Saint-Lambert, Belgium
Changde First People's HospitalRecruiting
Changde, China
Shandong Cancer Hospital And InstituteRecruiting
Jinan, China
Fudan University - Shanghai Cancer Center (FUSCC)Recruiting
Shanghai, China
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Zhengzhou, China
Fakultni nemocnice Motol a HomolkaRecruiting
Prague, Czechia
High Technology Hospital Medcenter LTDRecruiting
Batumi, Georgia
Multiprofile Clinic Consilium MedullaRecruiting
Tbilisi, Georgia
LLC Todua ClinicRecruiting
Tbilisi, Georgia
Caucasus Medical CentreRecruiting
Tbilisi, Georgia
Hämatologische-Onkologische Praxis AugsburgRecruiting
Augsburg, Germany
Praxis Fuer Interdisziplinaere Onkologie & HaematologieRecruiting
Freiburg im Breisgau, Germany
Institut fuer Versorgungsforschung in der OnkologieRecruiting
Koblenz, Germany
Centro di Riferimento Oncologico (CRO)Recruiting
Aviano, Italy
Azienda Unità Sanitaria Locale 2 (USL2) LuccaRecruiting
Lucca, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)Recruiting
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
Milan, Italy
IRCCS-Istituto Europeo di OncologiaRecruiting
Milan, Italy
Fondazione Policlinico Universitario Campus Bio-MedicoRecruiting
Roma, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto IRecruiting
Torrette, Italy
Chiba Cancer CenterRecruiting
Chiba, Japan
Fukushima Medical University HospitalRecruiting
Fukushima, Japan
Gifu University HospitalRecruiting
Gifu, Japan
Hiroshima City Hiroshima Citizens HospitalRecruiting
Hiroshima, Japan
Kumamoto University HospitalRecruiting
Kumamoto, Japan
Kyoto University HospitalRecruiting
Kyoto, Japan
National Hospital Organization Shikoku Cancer CenterRecruiting
Matsuyama, Japan
Nagoya City University HospitalRecruiting
Nagoya, Japan
Tohoku University HospitalRecruiting
Sendai, Japan
National Center For Global Health And MedicineRecruiting
Shinjuku-Ku, Japan
IP Clinic Sp. z o.o.Recruiting
Lodz, Poland
Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy Instytut BadawczyRecruiting
Warsaw, Poland
Soon Chun Hyang University Cheonan HospitalRecruiting
Cheonan, South Korea
Chungbuk National University HospitalRecruiting
Cheongju-si, South Korea
National Cancer CenterRecruiting
Goyang-si, South Korea
Seoul National University Bundang Hospital (SNUBH)Recruiting
Seongnam-si, South Korea
Korea University Anam HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical Center (AMC)Recruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Ajou University HospitalRecruiting
Suwon, South Korea
Hospital Universitario de BadajozRecruiting
Badajoz, Spain
Parc de Salut Mar - Hospital del MarRecruiting
Barcelona, Spain
Institut Oncologic Rosell - Hospital General De CatalunyaRecruiting
Barcelona, Spain
Hospital Universitario Reina SofiaRecruiting
Córdoba, Spain
IOB Institute of Oncology - Beata Maria Ana HospitalRecruiting
Madrid, Spain
Universidad de Navarra - Clinica Universidad de Navarra (CUN)Recruiting
Madrid, Spain
Hospital Universitario Fundación Jiménez DíazRecruiting
Madrid, Spain
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)Recruiting
Madrid, Spain
Hospital General Universitario Morales MeseguerRecruiting
Murcia, Spain
Hospital Universitario Virgen De La Arrixaca (Huva)Recruiting
Murcia, Spain
Universidad de Navarra - Clínica Universidad de Navarra (CUN)Recruiting
Pamplona, Spain
Hospital Universitari Parc TauliRecruiting
Sabadell, Spain
Fundación Instituto Valenciano de OncologíaRecruiting
Valencia, Spain
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation TrustRecruiting
Brighton, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology CentreRecruiting
Bristol, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill HospitalRecruiting
Cottingham, United Kingdom
Edinburgh Cancer Centre-Western General HospitalRecruiting
Edinburgh, United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS TrustRecruiting
Leeds, United Kingdom
St Bartholomew's Hospital - Barts Health NHS TrustRecruiting
London, United Kingdom
University College London Hospitals NHS Foundation TrustRecruiting
London, United Kingdom
The Royal Free Hospital - Royal Free London NHS Foundation TrustRecruiting
London, United Kingdom
Sarah Cannon Research InstituteRecruiting
London, United Kingdom
Churchill Hospital - Oxford University Hospitals NHS Foundation TrustRecruiting
Oxford, United Kingdom
North Wales Cancer Treatment C - Glan Clwyd HospitalRecruiting
Rhyl, United Kingdom
Southampton General Hospital - University Hospital Southampton NHS Foundation TrustRecruiting
Southampton, United Kingdom
Royal Stoke University Hospital - University Hospitals of North Midlands NHS TrustRecruiting
Stoke-on-Trent, United Kingdom
Torbay Hosptial, South Devon Healthcare NHS Foundation TrustRecruiting
Torquay, United Kingdom
New Cross Hospital - The Royal Wolverhampton NHS TrustRecruiting
Wolverhampton, United Kingdom
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer · TrialPath