Trial intelligence / Profile preview

ROSETTA Breast-01 pumitamig plus chemotherapy in first-line triple-negative breast cancer

NL-OMON59742Phase 3Recruiting

Sponsor
BioNTech SE
Start
Aug 2026
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics
Countries
1
01

Overview

Phase 3, randomised, double-blind trial in triple-negative breast cancer (TNBC) and breast cancer comparing pumitamig + chemotherapy with placebo + chemotherapy (2 arms). Primary endpoints: Overall survival and Progression-free survival by BICR. Started Aug 2026; status: recruiting.

02

Drugs

pumitamig
03

Conditions

triple-negative breast cancer (TNBC)breast cancer

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