Loading
Trastuzumab deruxtecan / Breast Cancer · Phase 3 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 registry record for T-DXd in previously-treated HER2-positive advanced/metastatic breast cancer, stratified by brain metastasis status at baseline. No results are posted in this registry record; the study evaluates ORR in participants without baseline brain metastases and 12-month PFS rate in those with baseline brain metastases.
Phase 3, Interventional, Single Group, Open label, Treatment purpose. Breast Cancer; age from 18 Years; to 130 Years. Intervention: Trastuzumab Deruxtecan. n = 506. 81 sites across 18 countries.
This is a Phase 3 registry record for T-DXd in previously-treated HER2-positive advanced/metastatic breast cancer, stratified by brain metastasis status at baseline. No results are posted in this registry record; the study evaluates ORR in participants without baseline brain metastases and 12-month PFS rate in those with baseline brain metastases.
No results are posted in this registry record; efficacy and safety outcomes are not reported.
The source did not state who this applies to in practice.
This is a Phase 3 trial registry record with no results posted; it describes planned enrollment and primary endpoints but carries no efficacy or safety data.
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 (NCT04739761). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 506 participants (ACTUAL). Conditions: Breast Cancer. Interventions: DRUG: Trastuzumab Deruxtecan. Primary outcome measures: Objective Response Rate (ORR) in Cohort 1 (Participants Without Brain Metastasis at Baseline) , From first dose (Day 1) to progression of disease (up to 2 years 7 months); Progression-free Survival (PFS) Rate at 12 Months in Cohort 2 (Participants With Brain Metastasis at Baseline) , At 12 months. Brief summary: This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.