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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID: NCT07173751
Run by: BioNTech SE
People needed: 558
Starts: 2025-10-30
Expected to finish: 2030-09-01
Last updated by the study team: 2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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