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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

Sponsor: BioNTech SE · Participants: 558 · Started: Oct 30, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07173751

Locations in the U.S.

ArkansasHighlands Oncology Group, Springdale
CaliforniaUniversity 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
FloridaFlorida Cancer Specialists, Fort Myers
Cancer Care Centers of Brevard, Inc, Palm Bay
Sacred Heart Medical Oncology Group, Pensacola
Florida Cancer Specialists North, St. Petersburg
IllinoisCancer Care Specialists, Decatur
Cancer Care Specialists of Illinois, O'Fallon
Carle Foundation Hospital d/b/a Carle Cancer Center, Urbana
KentuckyUniversity Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center, Louisville
MaineNew England Cancer Specialists, Westbrook
MarylandSaint Agnes Hospital, Clinical Research Center, Baltimore
Maryland Oncology Hematology P.A., Columbia
MassachusettsLahey Hospital & Medical Center, Burlington
MichiganKarmanos Cancer Center, Detroit
Profound Research LLC at Michigan Hematology and Oncology Consultants, Royal Oak
MinnesotaHealthpartners Regions Specialty Clinics, Saint Louis Park
Healthpartners Regions Specialty Clinics, Saint Paul
MissouriSaint Luke's Hospital of Kansas City, Kansas City
NebraskaOncology Hematology West, PC dba Nebraska Cancer Specialist, Grand Island
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha
New JerseySummit 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 YorkParadigm 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 CarolinaCarolina Oncology Specialists, Charlotte
Oncology Specialists of Charlotte Pa, Charlotte
OregonSt Charles Bend Cancer Center, Bend
Providence Portland Medical Center, Portland
St. Charles Cancer Center - Redmond, Redmond
Oregon Oncology Specialists, Salem
TennesseeThe West Clinic, P.C. dba West Cancer Center, Germantown
Tennessee Oncology, Nashville
TexasOneR 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
VirginiaBon Secours Cancer Institute at Memorial Regional, Mechanicsville
Bon Secours St. Francis Medical Center, Midlothian
Bon Secours Cancer Institute at St. Mary's, Richmond
WashingtonNorthwest Medical Specialties, PLLC, Tacoma
WisconsinMedical 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.