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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

2026-03-25

Healthy Volunteers

No

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

Locations (28)

Highlands Oncology Group

Springdale, Arkansas, United States

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

Palo Alto, California, 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

New England Cancer Specialists

Westbrook, Maine, United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Profound Research LLC at Michigan Hematology and Oncology Consultants

Royal Oak, Michigan, United States

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

Omaha, Nebraska, United States

Montefiore Medical Center

The Bronx, New York, United States

Oregon Oncology Specialists

Salem, Oregon, United States

The West Clinic, P.C. dba West Cancer Center

Germantown, Tennessee, United States

Oncology Consultants PA

Houston, Texas, United States

Oncology Consultants PA

Houston, Texas, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

GenesisCare St Andrew's Precinct

Adelaide, South Australia, Australia

Peninsula & South Eastern Hematology and Oncology Group

Frankston, Victoria, Australia

Fudan University - Shanghai Cancer Center (FUSCC)

Shanghai, China

High Technology Hospital Medcenter LTD

Batumi, Georgia

LLC Todua Clinic

Tbilisi, Georgia

Caucasus Medical Centre

Tbilisi, Georgia

Chungbuk National University Hospital

Cheongju-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Edinburgh Cancer Centre-Western General Hospital

Edinburgh, United Kingdom

Sarah Cannon Research Institute

London, United Kingdom

Torbay Hosptial, South Devon Healthcare NHS Foundation Trust

Torquay, United Kingdom

New Cross Hospital - The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom