drugset / Trial / NCT07173751
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2025-10-30
- Primary completion
- 2029-12
- Completion
- 2030-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pumitamig | Protein / enzyme biologic | — | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Eribulin | Small molecule | — | Intravenous |
| Background | Gemcitabine | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |