Clinical Trial

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

Recruiting Phase 3
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.
Protocol Amendment History 6 changes
notable Trial sites expanded: 155 -> 161 locations 2026-08-04
notable Trial sites expanded: 143 -> 155 locations 2026-07-19
notable Trial sites expanded: 104 -> 143 locations 2026-06-26
notable Trial sites expanded: 83 -> 104 locations 2026-05-23
notable Trial sites expanded: 63 -> 83 locations 2026-05-02
notable Trial sites expanded: 28 -> 63 locations 2026-04-22
Trial Details
NCT Number NCT07173751
Lead Sponsor BioNTech SE
Collaborators: Bristol-Myers Squibb
Conditions Breast Neoplasms
Enrollment 558 participants
Start Date 2025-10-30
Primary Completion 2029-12 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-03