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

Source: https://onco.cc/trials/nct07173751/  
OnCo record `nct07173751` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of PM8002, Gemcitabine, Carboplatin and Eribulin in triple-negative breast cancer, run by BioNTech SE, now recruiting.

## Summary

ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer is a phase 3 interventional study registered as NCT07173751 by BioNTech SE, with 558 participants planned, started 2025-10-30 and due to reach its primary completion in 2029-12. Interventions recorded: Pumitamig, Nab-paclitaxel/Paclitaxel, Gemcitabine, Carboplatin, Eribulin and Matching placebo.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT07173751
- Phase: 3
- Setting: 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
- Sponsor: BioNTech SE
- Enrolled: 558

## Sources

- ClinicalTrials.gov NCT07173751: https://clinicaltrials.gov/study/NCT07173751

## Connected records

- cancers: [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Eribulin](https://onco.cc/drugs/eribulin/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [PM8002](https://onco.cc/drugs/pm8002/)
- companies: [BioNTech](https://onco.cc/companies/biontech/), [Bristol Myers Squibb](https://onco.cc/companies/bms/)

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