Phase 3Recruiting
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
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 (Industry)
- Enrolment
- 558 planned
- Conditions
- Breast Neoplasms
- Interventions
- Pumitamig; Nab-paclitaxel/Paclitaxel; Gemcitabine; Carboplatin; Eribulin; Matching placebo
- Ages
- adults, older adults
- Registry
- NCT07173751, CTIS2025-521884-12-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
- Overall Survival (OS)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered