Home › Breast Cancer › NCT07173751
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
RecruitingPhase 3
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
Who can join
Ages 18 and older · All sexes
Full 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.
About the 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.
What is being tested
- Pumitamig (drug)
- Nab-paclitaxel/Paclitaxel (drug)
- Gemcitabine (drug)
- Carboplatin (drug)
- Eribulin (drug)
- Matching placebo (drug)
Sponsor: BioNTech SE · Participants: 558 · Started: Oct 30, 2025
Contact the study team
- BioNTech clinical trials patient information · Phone: +49 6131 9084
Official record on ClinicalTrials.gov — NCT07173751
Locations in the U.S.
| Arkansas | Highlands Oncology Group, Springdale |
| California | University Of California - San Diego Moores Cancer Center, La Jolla Cancer and Blood Specialty Clinic (CBSC), Los Alamitos Cedar Sinai - Samuel Oschin Cancer Center, Los Angeles Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center, Palo Alto University Of California Davis Health System, Sacramento Sansum Clinic, Santa Barbara Saint John's Health Center - John Wayne Cancer Institute (JWCI), Santa Monica |
| Florida | Florida Cancer Specialists, Fort Myers Cancer Care Centers of Brevard, Inc, Palm Bay Sacred Heart Medical Oncology Group, Pensacola Florida Cancer Specialists North, St. Petersburg |
| Illinois | Cancer Care Specialists, Decatur Cancer Care Specialists of Illinois, O'Fallon Carle Foundation Hospital d/b/a Carle Cancer Center, Urbana |
| Kentucky | University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center, Louisville |
| Maine | New England Cancer Specialists, Westbrook |
| Maryland | Saint Agnes Hospital, Clinical Research Center, Baltimore Maryland Oncology Hematology P.A., Columbia |
| Massachusetts | Lahey Hospital & Medical Center, Burlington |
| Michigan | Karmanos Cancer Center, Detroit Profound Research LLC at Michigan Hematology and Oncology Consultants, Royal Oak |
| Minnesota | Healthpartners Regions Specialty Clinics, Saint Louis Park Healthpartners Regions Specialty Clinics, Saint Paul |
| Missouri | Saint Luke's Hospital of Kansas City, Kansas City |
| Nebraska | Oncology Hematology West, PC dba Nebraska Cancer Specialist, Grand Island Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha |
| New Jersey | Summit Medical Group PA, Florham Park Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey), Livingston Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey), Long Branch Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey), New Brunswick Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey), Newark Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey), Somerville Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey), Toms River |
| New York | Paradigm New York Cancer and Blood Specialists, Bay Shore Paradigm New York Cancer and Blood Specialists, New York Paradigm New York Cancer and Blood Specialists, New York Paradigm New York Cancer and Blood Specialists, New York Paradigm New York Cancer and Blood Specialists, New York Paradigm New York Cancer and Blood Specialists, New York Paradigm New York Cancer and Blood Specialists, New York Paradigm New York Cancer and Blood Specialists, New York Paradigm New York Cancer and Blood Specialists, New York Rochester General Hospital Lipson Cancer Institute, Rochester Stony Brook University Medical Center, Stony Brook Montefiore Medical Center, The Bronx |
| North Carolina | Carolina Oncology Specialists, Charlotte Oncology Specialists of Charlotte Pa, Charlotte |
| Oregon | St Charles Bend Cancer Center, Bend Providence Portland Medical Center, Portland St. Charles Cancer Center - Redmond, Redmond Oregon Oncology Specialists, Salem |
| Tennessee | The West Clinic, P.C. dba West Cancer Center, Germantown Tennessee Oncology, Nashville |
| Texas | OneR The Center For Cancer And Blood Disorders (Texas Cancer Care), Arlington OneR The Center For Cancer And Blood Disorders (Texas Cancer Care), Burleson UT Southwestern Medical Center at Redbird, Dallas University Of Texas Southwestern Medical Center, Dallas JPS Health Network - Trinity Springs Pavilion, Fort Worth OneR The Center For Cancer And Blood Disorders (Texas Cancer Care), Fort Worth UT Southwestern Moncrief Cancer Institute, Fort Worth Oncology Consultants PA, Houston Oncology Consultants PA, Houston UT Southwestern Medical Center at Richardson/Plano, Richardson Renovatio Clinical - The Woodlands Research Center, The Woodlands OneR The Center For Cancer And Blood Disorders (Texas Cancer Care), Weatherford |
| Virginia | Bon Secours Cancer Institute at Memorial Regional, Mechanicsville Bon Secours St. Francis Medical Center, Midlothian Bon Secours Cancer Institute at St. Mary's, Richmond |
| Washington | Northwest Medical Specialties, PLLC, Tacoma |
| Wisconsin | Medical College of Wisconsin, Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.