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Pumitamig / Nab-paclitaxel/Paclitaxel / Breast Neoplasms · Phase 3 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
ROSETTA Breast-01 is an active Phase 3, randomized, double-blind, placebo-controlled trial comparing pumitamig plus chemotherapy versus placebo plus chemotherapy in triple-negative breast cancer. No results are yet available; this registry record describes the planned study design and endpoints only.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Breast Neoplasms; age from 18 Years. Intervention: Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Ch…. Compared with: Arm 2: Placebo + TPC Chemotherapy — Placebo Comparator. n = 558. 181 sites across 16 countries.
ROSETTA Breast-01 is an active Phase 3, randomized, double-blind, placebo-controlled trial comparing pumitamig plus chemotherapy versus placebo plus chemotherapy in triple-negative breast cancer. No results are yet available; this registry record describes the planned study design and endpoints only.
This is a registry record only; no clinical outcomes, efficacy data, or safety results are reported.
This trial design is appropriate for a definitive assessment of pumitamig efficacy in triple-negative breast cancer, but clinicians should await full results before drawing conclusions. Interim or final results, when published, should be evaluated for effect size, hazard ratios, and subgroup outcomes.
This is a clinical trial registry record describing a Phase 3 RCT that is currently recruiting with no results posted; the study design is rigorous but outcomes are not yet available.
As stated by the source record.
Quoted from the source exactly as published.
This trial design is appropriate for a definitive assessment of pumitamig efficacy in triple-negative breast cancer, but clinicians should await full results before drawing conclusions. Interim or final results, when published, should be evaluated for effect size, hazard ratios, and subgroup outcomes.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07173751). This is a study registration, not published results. Lead sponsor: BioNTech SE. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 558 participants (ESTIMATED). Conditions: Breast Neoplasms. Interventions: DRUG: Pumitamig; DRUG: Nab-paclitaxel/Paclitaxel; DRUG: Gemcitabine; DRUG: Carboplatin; DRUG: Eribulin; DRUG: Matching placebo. Primary outcome measures: Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) , Up to approximately 32 months; Overall Survival (OS) , Up to approximately 49 months. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.