Actively Recruiting
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Led by BioNTech SE · Updated on 2026-05-01
558
Participants Needed
83
Research Sites
252 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Considered ineligible for PD(L)1 immunotherapy plus chemotherapy based on tumor PD-L1 status
- Have confirmed locally recurrent inoperable or metastatic triple-negative breast cancer or ER-low, HER2-negative breast cancer documented before screening
- Have at least one measurable lesion per RECIST v1.1
- Provide a suitable tissue sample (not bone biopsy, fine needle aspiration, or pleural/peritoneal fluid)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Prior systemic anticancer therapy for advanced disease
- Prior treatment with PD(L)-1/VEGF bispecific antibody
- Use of systemic corticosteroids >10 mg/day prednisone or equivalent within 7 days before trial, except certain local or short-term uses
- Vaccination with live attenuated vaccines within 4 weeks before trial
- Use of broad-spectrum intravenous antibiotics within 2 weeks before trial
- Pregnant, breastfeeding, or planning pregnancy/fathering children during trial or within 6 months after last dose
- Major organ surgery, significant trauma, or invasive dental procedures within 28 days before trial or planned elective surgery during trial
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 83 locations
1
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
Actively Recruiting
2
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
Palo Alto, California, United States, 94304-2201
Actively Recruiting
3
Cancer Care Specialists
Decatur, Illinois, United States, 62526
Actively Recruiting
4
Cancer Care Specialists of Illinois
O'Fallon, Illinois, United States, 62269
Actively Recruiting
5
Carle Foundation Hospital d/b/a Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
6
New England Cancer Specialists
Westbrook, Maine, United States, 04092
Actively Recruiting
7
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
8
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Actively Recruiting
9
Profound Research LLC at Michigan Hematology and Oncology Consultants
Royal Oak, Michigan, United States, 48073
Actively Recruiting
10
Oncology Hematology West, PC dba Nebraska Cancer Specialist
Grand Island, Nebraska, United States, 68803
Actively Recruiting
11
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68310
Actively Recruiting
12
Summit Medical Group PA
Florham Park, New Jersey, United States, 07932
Actively Recruiting
13
Rochester General Hospital Lipson Cancer Institute
Rochester, New York, United States, 14621
Actively Recruiting
14
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
15
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
16
Oregon Oncology Specialists
Salem, Oregon, United States, 97301
Actively Recruiting
17
The West Clinic, P.C. dba West Cancer Center
Germantown, Tennessee, United States, 38002
Actively Recruiting
18
Oncology Consultants PA
Houston, Texas, United States, 77024
Actively Recruiting
19
Oncology Consultants PA
Houston, Texas, United States, 77030
Actively Recruiting
20
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
Actively Recruiting
21
GenesisCare St Andrew's Precinct
Adelaide, South Australia, Australia, 50000
Actively Recruiting
22
Peninsula & South Eastern Hematology and Oncology Group
Frankston, Victoria, Australia, 3199
Actively Recruiting
23
Westmead Hospital
Westmead, Australia, 2145
Actively Recruiting
24
Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
Brussels, Belgium, 1090
Actively Recruiting
25
Grand hospital de Charleroi
Gilly, Belgium, 6060
Actively Recruiting
26
University Hospitals Leuven
Leuven, Belgium, 3000
Actively Recruiting
27
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium, 1200
Actively Recruiting
28
Changde First People's Hospital
Changde, China, 415003
Actively Recruiting
29
Fudan University - Shanghai Cancer Center (FUSCC)
Shanghai, China, 200032
Actively Recruiting
30
High Technology Hospital Medcenter LTD
Batumi, Georgia, 6000
Actively Recruiting
31
Multiprofile Clinic Consilium Medulla
Tbilisi, Georgia, 0168
Actively Recruiting
32
LLC Todua Clinic
Tbilisi, Georgia, 112
Actively Recruiting
33
Caucasus Medical Centre
Tbilisi, Georgia, 186
Actively Recruiting
34
Praxis Fuer Interdisziplinaere Onkologie & Haematologie
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
35
Institut fuer Versorgungsforschung in der Onkologie
Koblenz, Germany, 56068
Actively Recruiting
36
Centro di Riferimento Oncologico (CRO)
Aviano, Italy, 33081
Actively Recruiting
37
Azienda Unità Sanitaria Locale 2 (USL2) Lucca
Lucca, Italy, 55100
Actively Recruiting
38
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, Italy, 20132
Actively Recruiting
39
IRCCS-Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
40
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy, 00128
Actively Recruiting
41
Chiba Cancer Center
Chiba, Japan, 260-8717
Actively Recruiting
42
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Actively Recruiting
43
Gifu University Hospital
Gifu, Japan, 501-1112
Actively Recruiting
44
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan, 730-8518
Actively Recruiting
45
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Actively Recruiting
46
Nagoya City University Hospital
Nagoya, Japan, 467-8602
Actively Recruiting
47
Tohoku University Hospital
Sendai, Japan, 980-8574
Actively Recruiting
48
National Center For Global Health And Medicine
Shinjuku-Ku, Japan, 162-8655
Actively Recruiting
49
IP Clinic Sp. z o.o.
Lodz, Poland, 90-752
Actively Recruiting
50
Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Poland, 02-781
Actively Recruiting
51
Soon Chun Hyang University Cheonan Hospital
Cheonan, South Korea, 31151
Actively Recruiting
52
Chungbuk National University Hospital
Cheongju-si, South Korea, 28644
Actively Recruiting
53
National Cancer Center
Goyang-si, South Korea, 10408
Actively Recruiting
54
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si, South Korea, 13620
Actively Recruiting
55
Korea University Anam Hospital
Seoul, South Korea, 2841
Actively Recruiting
56
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 3722
Actively Recruiting
57
Asan Medical Center (AMC)
Seoul, South Korea, 5505
Actively Recruiting
58
Samsung Medical Center
Seoul, South Korea, 6351
Actively Recruiting
59
Ajou University Hospital
Suwon, South Korea, 16499
Actively Recruiting
60
Hospital Universitario de Badajoz
Badajoz, Spain, 6006
Actively Recruiting
61
Parc de Salut Mar - Hospital del Mar
Barcelona, Spain, 8003
Actively Recruiting
62
Institut Oncologic Rosell - Hospital General De Catalunya
Barcelona, Spain, 8195
Actively Recruiting
63
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
64
IOB Institute of Oncology - Beata Maria Ana Hospital
Madrid, Spain, 28007
Actively Recruiting
65
Universidad de Navarra - Clinica Universidad de Navarra (CUN)
Madrid, Spain, 28027
Actively Recruiting
66
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
67
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, Spain, 28050
Actively Recruiting
68
Hospital General Universitario Morales Meseguer
Murcia, Spain, 30008
Actively Recruiting
69
Hospital Universitario Virgen De La Arrixaca (Huva)
Murcia, Spain, 30120
Actively Recruiting
70
Universidad de Navarra - Clínica Universidad de Navarra (CUN)
Pamplona, Spain, 31008
Actively Recruiting
71
Hospital Universitari Parc Tauli
Sabadell, Spain, 8208
Actively Recruiting
72
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom, BN2 5BE
Actively Recruiting
73
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
74
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
75
Edinburgh Cancer Centre-Western General Hospital
Edinburgh, United Kingdom, EH4 2LF
Actively Recruiting
76
St Bartholomew's Hospital - Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Actively Recruiting
77
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW2 1PG
Actively Recruiting
78
The Royal Free Hospital - Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Actively Recruiting
79
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Actively Recruiting
80
North Wales Cancer Treatment C - Glan Clwyd Hospital
Rhyl, United Kingdom, LL18 5UJ
Actively Recruiting
81
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
82
Torbay Hosptial, South Devon Healthcare NHS Foundation Trust
Torquay, United Kingdom, TQ2 7AA
Actively Recruiting
83
New Cross Hospital - The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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