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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
2026-03-25
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 (28)
Highlands Oncology Group
Springdale, Arkansas, United States
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
Palo Alto, California, 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
New England Cancer Specialists
Westbrook, Maine, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Profound Research LLC at Michigan Hematology and Oncology Consultants
Royal Oak, Michigan, United States
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 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
GenesisCare St Andrew's Precinct
Adelaide, South Australia, Australia
Peninsula & South Eastern Hematology and Oncology Group
Frankston, Victoria, Australia
Fudan University - Shanghai Cancer Center (FUSCC)
Shanghai, China
High Technology Hospital Medcenter LTD
Batumi, Georgia
LLC Todua Clinic
Tbilisi, Georgia
Caucasus Medical Centre
Tbilisi, Georgia
Chungbuk National University Hospital
Cheongju-si, South Korea
Korea University Anam Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Edinburgh Cancer Centre-Western General Hospital
Edinburgh, United Kingdom
Sarah Cannon Research Institute
London, United Kingdom
Torbay Hosptial, South Devon Healthcare NHS Foundation Trust
Torquay, United Kingdom
New Cross Hospital - The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom