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RECRUITING

NCT07173751

PHASE3

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

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

558

Start Date

2025-10-30

Completion Date

2030-09

Last Updated

2026-10-06

Healthy Volunteers

Conditions

Breast Neoplasms

Interventions

DRUG

Pumitamig

Solution for intravenous (IV) infusion

DRUG

Nab-paclitaxel/Paclitaxel

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Eribulin

IV infusion

DRUG

Matching placebo

IV infusion

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.

Locations (212)

Highlands Oncology Group

Springdale, Arkansas, United States

University Of California - San Diego Moores Cancer Center

La Jolla, California, United States

Cancer and Blood Specialty Clinic (CBSC)

Los Alamitos, California, United States

Cedar Sinai - Samuel Oschin Cancer Center

Los Angeles, California, United States

Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center

Palo Alto, California, United States

University Of California Davis Health System

Sacramento, California, United States

Sansum Clinic

Santa Barbara, California, United States

Saint John's Health Center - John Wayne Cancer Institute (JWCI)

Santa Monica, California, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Cancer Care Centers of Brevard, Inc

Palm Bay, Florida, United States

Sacred Heart Medical Oncology Group

Pensacola, Florida, United States

Florida Cancer Specialists North

St. Petersburg, Florida, United States

Cancer Care Specialists

Decatur, Illinois, United States

Cancer Care Specialists of Illinois

O'Fallon, Illinois, United States

Carle Foundation Hospital d/b/a Carle Cancer Center

Urbana, Illinois, United States

University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center

Louisville, Kentucky, United States

New England Cancer Specialists

Westbrook, Maine, United States

Saint Agnes Hospital, Clinical Research Center

Baltimore, Maryland, United States

Maryland Oncology Hematology P.A.

Columbia, Maryland, United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Karmanos Cancer Center

Detroit, Michigan, United States

Profound Research LLC at Michigan Hematology and Oncology Consultants

Royal Oak, Michigan, United States

Healthpartners Regions Specialty Clinics

Saint Louis Park, Minnesota, United States

Healthpartners Regions Specialty Clinics

Saint Paul, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialist

Grand Island, Nebraska, United States

Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Summit Medical Group PA

Florham Park, New Jersey, United States

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

Livingston, New Jersey, United States

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

Long Branch, New Jersey, United States

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

New Brunswick, New Jersey, United States

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

Newark, New Jersey, United States

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

Somerville, New Jersey, United States

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

Toms River, New Jersey, United States