ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
← catalyst calendarNCT07173751 · readout ≤ 1,229 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With Bristol-Myers Squibb.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
558estimated
Sites
161
Countries
Australia, Belgium, Brazil +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-30 | actual | When the study began enrolling |
| Primary completion | Dec 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2025-09-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Breast Neoplasms
Interventions
- Drug: Pumitamig — also filed as BNT327, PM8002, BMS-986545
- Drug: Nab-paclitaxel/Paclitaxel
- Drug: Gemcitabine
- Drug: Carboplatin
- Drug: Eribulin
- Drug: Matching placebo
Primary outcomes
what the primary-completion date above is the date OFProgression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
measured Up to approximately 32 months
Overall Survival (OS)
measured Up to approximately 49 months
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