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Nab-paclitaxel / Durvalumab / Breast Cancer · Phase 3 Trial
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 trial registration for TROPION-Breast05, a planned comparison of Dato-DXd (with or without durvalumab) versus investigator's choice chemotherapy plus pembrolizumab in PD-L1–positive metastatic or locally recurrent inoperable triple-negative breast cancer. No results have been posted to the registry; the study is currently recruiting.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Breast Cancer; age from 18 Years. Intervention: Dato-DXd + durvalumab; Dato-DXd. Compared with: Investigator's Choice of Chemotherapy (ICC) in combination… — Active Comparator. n = 625. 320 sites across 24 countries.
This is a Phase 3 trial registration for TROPION-Breast05, a planned comparison of Dato-DXd (with or without durvalumab) versus investigator's choice chemotherapy plus pembrolizumab in PD-L1–positive metastatic or locally recurrent inoperable triple-negative breast cancer. No results have been posted to the registry; the study is currently recruiting.
This registry record contains no efficacy or safety results; study is currently recruiting and outcomes are not yet available
The source did not state who this applies to in practice.
This is a Phase 3 trial registration with no reported results; the study is actively recruiting and outcome data are not yet available.
As stated by the source record.
Quoted from the source exactly as published.
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 (NCT06103864). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 625 participants (ESTIMATED). Conditions: Breast Cancer. Interventions: DRUG: Dato-DXd; DRUG: Durvalumab; DRUG: Paclitaxel; DRUG: Nab-paclitaxel; DRUG: Gemcitabine; DRUG: Carboplatin; DRUG: Pembrolizumab. Primary outcome measures: Progression Free Survival (PFS) , From randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause (anticipated to be up to 33 months).. Brief summary: This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
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