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Clinical Trials in the USA / NCT07173751
Recruiting Phase 3

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

NCT07173751 · tracked via the Priya Life Science USA tracker
Sponsor
BioNTech SE
Phase
Phase 3
Started
2025-10-30
Last updated
2026-09-17

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

PumitamigNab-paclitaxel/PaclitaxelGemcitabineCarboplatinEribulinMatching placebo

Pumitamig: Solution for intravenous (IV) infusion

Nab-paclitaxel/Paclitaxel: IV infusion

Gemcitabine: IV infusion

Carboplatin: IV infusion

Eribulin: IV infusion

Matching placebo: IV infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (202)

FacilityCityRegionStatus
Highlands Oncology Group Springdale Arkansas Recruiting
University Of California - San Diego Moores Cancer Center La Jolla California Recruiting
Cancer and Blood Specialty Clinic (CBSC) Los Alamitos California Recruiting
Cedar Sinai - Samuel Oschin Cancer Center Los Angeles California Recruiting
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center Palo Alto California Recruiting
University Of California Davis Health System Sacramento California Recruiting
Sansum Clinic Santa Barbara California Recruiting
Saint John's Health Center - John Wayne Cancer Institute (JWCI) Santa Monica California Recruiting
Florida Cancer Specialists Fort Myers Florida Recruiting
Cancer Care Centers of Brevard, Inc Palm Bay Florida Recruiting
Sacred Heart Medical Oncology Group Pensacola Florida Recruiting
Florida Cancer Specialists North St. Petersburg Florida Recruiting
Cancer Care Specialists Decatur Illinois Recruiting
Cancer Care Specialists of Illinois O'Fallon Illinois Recruiting
Carle Foundation Hospital d/b/a Carle Cancer Center Urbana Illinois Recruiting
University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center Louisville Kentucky Recruiting
New England Cancer Specialists Westbrook Maine Recruiting
Saint Agnes Hospital, Clinical Research Center Baltimore Maryland Recruiting
Maryland Oncology Hematology P.A. Columbia Maryland Recruiting
Lahey Hospital & Medical Center Burlington Massachusetts Recruiting
Karmanos Cancer Center Detroit Michigan Recruiting
Profound Research LLC at Michigan Hematology and Oncology Consultants Royal Oak Michigan Recruiting
Healthpartners Regions Specialty Clinics Saint Louis Park Minnesota Recruiting
Healthpartners Regions Specialty Clinics Saint Paul Minnesota Recruiting
Saint Luke's Hospital of Kansas City Kansas City Missouri Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialist Grand Island Nebraska Recruiting
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha Nebraska Recruiting
Summit Medical Group PA Florham Park New Jersey Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) Livingston New Jersey Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) Long Branch New Jersey Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) New Brunswick New Jersey Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) Newark New Jersey Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) Somerville New Jersey Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) Toms River New Jersey Recruiting
Paradigm New York Cancer and Blood Specialists Bay Shore New York Recruiting
Paradigm New York Cancer and Blood Specialists New York New York Recruiting
Paradigm New York Cancer and Blood Specialists New York New York Recruiting
Paradigm New York Cancer and Blood Specialists New York New York Recruiting
Paradigm New York Cancer and Blood Specialists New York New York Recruiting
Paradigm New York Cancer and Blood Specialists New York New York Recruiting

+ 162 more sites — see the full list on the official registry below.

More BioNTech SE trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07173751 on ClinicalTrials.gov ↗ ← All trials in the USA