Tests pumitamig with chemotherapy in triple-negative breast cancer
Compares pumitamig plus chemotherapy with placebo plus chemotherapy in adults with breast cancer.
Plain-language title generated from the registry record
Registry title: ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Key facts
- Where
- Arlington, Baltimore, Bay Shore, Bend, Burleson, Burlington, Charlotte, Columbia, Dallas, Decatur, Detroit, Florham Park, Fort Myers, Fort Worth, Germantown, Grand Island, Houston, Kansas City, La Jolla, Livingston, Long Branch, Los Alamitos, Los Angeles, Louisville, Mechanicsville, Midlothian, Milwaukee, Nashville, New Brunswick, New York, Newark, O'Fallon, Omaha, Palm Bay, Palo Alto, Pensacola, Portland, Redmond, Richardson, Richmond, Rochester, Royal Oak, Sacramento, Saint Louis Park, Saint Paul, Salem, Santa Barbara, Santa Monica, Somerville, Springdale, St. Petersburg, Stony Brook, Tacoma, The Bronx, The Woodlands, Toms River, Urbana, Weatherford, and Westbrook, United StatesSee the 63 sites
- Phase
- Phase 3
Where in United States
- OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)Arlington, United StatesTaking people
- Saint Agnes Hospital, Clinical Research CenterBaltimore, United StatesTaking people
- Paradigm New York Cancer and Blood SpecialistsBay Shore, United StatesTaking people
- St Charles Bend Cancer CenterBend, United StatesTaking people
- OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)Burleson, United StatesTaking people
- Lahey Hospital & Medical CenterBurlington, United StatesTaking people
- Carolina Oncology SpecialistsCharlotte, United StatesTaking people
- Oncology Specialists of Charlotte PaCharlotte, United StatesTaking people
- Maryland Oncology Hematology P.A.Columbia, United StatesTaking people
- University of Texas Southwestern Medical CenterDallas, United StatesTaking people
- UT Southwestern Medical Center at RedbirdDallas, United StatesTaking people
- Cancer Care SpecialistsDecatur, United StatesTaking people
- Karmanos Cancer CenterDetroit, United StatesTaking people
- Summit Medical Group PAFlorham Park, United StatesTaking people
- Florida Cancer SpecialistsFort Myers, United StatesTaking people
- JPS Health Network - Trinity Springs PavilionFort Worth, United StatesTaking people
- OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)Fort Worth, United StatesTaking people
- UT Southwestern Moncrief Cancer InstituteFort Worth, United StatesTaking people
- The West Clinic, P.C. dba West Cancer CenterGermantown, United StatesTaking people
- Oncology Hematology West, PC dba Nebraska Cancer SpecialistGrand Island, United StatesTaking people
- Oncology Consultants, PAHouston, United StatesTaking people
- Saint Luke's Hospital of Kansas CityKansas City, United StatesTaking people
- University of California San Diego Moores Cancer CenterLa Jolla, United StatesTaking people
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)Livingston, United StatesTaking people
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)Long Branch, United StatesTaking people
- Cancer and Blood Specialty Clinic (CBSC)Los Alamitos, United StatesTaking people
- Cedar Sinai - Samuel Oschin Cancer CenterLos Angeles, United StatesTaking people
- University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer CenterLouisville, United StatesTaking people
- Bon Secours Cancer Institute at Memorial RegionalMechanicsville, United StatesTaking people
- Bon Secours St. Francis Medical CenterMidlothian, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- Tennessee OncologyNashville, United StatesTaking people
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)New Brunswick, United StatesTaking people
- Paradigm New York Cancer and Blood SpecialistsNew York, United StatesTaking people
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)Newark, United StatesTaking people
- Cancer Care Specialists of IllinoisO'Fallon, United StatesTaking people
- Paradigm Oncology Hematology West P.C. dba Nebraska Cancer SpecialistsOmaha, United StatesTaking people
- Cancer Care Centers of Brevard, Inc.Palm Bay, United StatesTaking people
- Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer CenterPalo Alto, United StatesTaking people
- Sacred Heart Medical Oncology GroupPensacola, United StatesTaking people
- Providence Portland Medical CenterPortland, United StatesTaking people
- St. Charles Cancer Center - RedmondRedmond, United StatesTaking people
- UT Southwestern Medical Center at Richardson/PlanoRichardson, United StatesTaking people
- Bon Secours Cancer Institute at St. Mary'sRichmond, United StatesTaking people
- Rochester General Hospital Lipson Cancer InstituteRochester, United StatesTaking people
- Profound Research LLC at Michigan Hematology and Oncology ConsultantsRoyal Oak, United StatesTaking people
- University of California Davis Health SystemSacramento, United StatesTaking people
- HealthPartners Regions Specialty ClinicsSaint Louis Park, United StatesTaking people
- Healthpartners Regions Specialty ClinicsSaint Paul, United StatesTaking people
- Oregon Oncology SpecialistsSalem, United StatesTaking people
- Sansum ClinicSanta Barbara, United StatesTaking people
- Saint John's Health Center - John Wayne Cancer Institute (JWCI)Santa Monica, United StatesTaking people
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)Somerville, United StatesTaking people
- Highlands Oncology GroupSpringdale, United StatesTaking people
- Florida Cancer Specialists - NorthSt. Petersburg, United StatesTaking people
- Stony Brook University Medical CenterStony Brook, United StatesTaking people
- Northwest Medical Specialties PLLCTacoma, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- Renovatio Clinical - The Woodlands Research CenterThe Woodlands, United StatesTaking people
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)Toms River, United StatesTaking people
- Carle Foundation Hospital d/b/a Carle Cancer CenterUrbana, United StatesTaking people
- OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)Weatherford, United StatesTaking people
- New England Cancer SpecialistsWestbrook, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BioNTech SE
- Trial code
- NCT07173751EU 2025-521884-12-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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; 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.