Trial Profile

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

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 25 Feb 2026

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At a glance

Drugs Carboplatin (Primary) ; Eribulin (Primary) ; Gemcitabine (Primary) ; Paclitaxel (Primary) ; Pumitamig (Primary)
Indications HER2 negative breast cancer; Triple negative breast cancer
Focus Registrational; Therapeutic Use
Acronyms ROSETTA Breast-01
Sponsors BioNTech

14 Nov 2025 Status changed from not yet recruiting to recruiting.
19 Sep 2025 New trial record
04 Aug 2025 According to the BioNTech Media Release, this study is planned to start in 2025.

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