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Study identifier: NCT07173751 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Breast Neoplasms  ·  Sponsor: BioNTech SE

PhasePhase 3
Planned participants558
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

BioNTech clinical trials patient information  ·  +49 6131 9084  ·  patients@biontech.de

Always discuss trial participation with your own doctor first.

Locations (155)

Highlands Oncology GroupSpringdale, Arkansas, United StatesRecruiting
University Of California - San Diego Moores Cancer CenterLa Jolla, California, United StatesRecruiting
Cedar Sinai - Samuel Oschin Cancer CenterLos Angeles, California, United StatesRecruiting
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer CenterPalo Alto, California, United StatesRecruiting
Sacred Heart Medical Oncology GroupPensacola, Florida, United StatesRecruiting
Cancer Care SpecialistsDecatur, Illinois, United StatesRecruiting
Cancer Care Specialists of IllinoisO'Fallon, Illinois, United StatesRecruiting
Carle Foundation Hospital d/b/a Carle Cancer CenterUrbana, Illinois, United StatesRecruiting
University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer CenterLouisville, Kentucky, United StatesRecruiting
New England Cancer SpecialistsWestbrook, Maine, United StatesRecruiting
Saint Agnes Hospital, Clinical Research CenterBaltimore, Maryland, United StatesRecruiting
Lahey Hospital & Medical CenterBurlington, Massachusetts, United StatesRecruiting

+ 143 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07173751