Trial reportNeuro-oncology2024
Final outcome analysis from the phase II TUXEDO-1 trial of trastuzumab-deruxtecan in HER2-positive breast cancer patients with active brain metastases.
Trial report in Neuro-oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
49 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Guidance for Canadian Breast Cancer Practice: National Consensus Recommendations for the Systemic Treatment of Patients with HER2+ Breast Cancer in Both the Early and Metastatic Settings (2025 Update).Current oncology (Toronto, Ont.) · 2026Guideline
- Pooled it
- Guidance for Canadian Breast Cancer Practice: National Consensus Recommendations for the Systemic Treatment of Patients with HER2+ Breast Cancer in Both the Early and Metastatic Setting.Current oncology (Toronto, Ont.) · 2024Guideline
- Patritumab deruxtecan in leptomeningeal metastatic disease of solid tumors: the phase 2 TUXEDO-3 trial.Nature medicine · 2025Trial
- Treatment With Etirinotecan Pegol for Patients With Metastatic Breast Cancer and Brain Metastases: Final Results From the Phase 3 ATTAIN Randomized Clinical Trial.JAMA oncology · 2022Trial
- Brain-only metastatic breast cancer as a distinct clinical entity: evidence from national and institutional cohorts with implications for radiation therapy.Breast cancer research and treatment · 2026Article
- Impact of trastuzumab deruxtecan (T-DXd) and brain stereotactic radiosurgery on intracranial control and radionecrosis risk in HER2-positive or -low breast cancer brain metastases.Breast (Edinburgh, Scotland) · 2026Observational
- Intracranial activity of mirvetuximab soravtansine in platinum-resistant high-grade serous ovarian cancer: Insights from a patient with central nervous system metastasis.Gynecologic oncology reports · 2026Article
- Too much, too soon?-trastuzumab deruxtecan in the first line metastatic setting.Translational cancer research · 2026Article
- Long-term safety and efficacy of staged stereotactic radiosurgery with Ommaya reservoir aspiration for large cystic brain metastases.Journal of neuro-oncology · 2026Article
- Review
- Focusing on toxicity management: Challenges and strategies for HER2-targeted antibody-drug conjugates in breast cancer.Breast (Edinburgh, Scotland) · 2026Review
- Article
- Management of Early and Metastatic Breast Cancer: A Consensus Statement from Oncologists in Saudi Arabia.Oncology and therapy · 2026Article
- Breast Cancer Brain Metastases: Current Understanding and Future Directions.Current oncology reports · 2026Review
- [European journal of nuclear medicine and molecular imaging · 2026Article
- The evolving landscape of brain metastasis: volume II.Trends in cancer · 2026Review
- Trastuzumab deruxtecan in advanced breast cancer patients with brain metastases or leptomeningeal metastases.Cancer pathogenesis and therapy · 2026Article
- Trastuzumab deruxtecan in HER2-positive metastatic breast cancer with severe hepatic dysfunction: a case report and narrative literature review.Frontiers in oncology · 2026Article
- Decoding the mechanisms underlying breast cancer brain metastasis: paving the way for precision therapeutics.Biomarker research · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors.
Funding
Abstract
backgroundBrain metastases (BM) are a devastating complication of HER2-positive metastatic breast cancer (BC) and treatment strategies providing optimized local and systemic disease control are urgently required. The antibody-drug conjugate trastuzumab deruxtecan (T-DXd) improved progression-free survival (PFS) and overall survival (OS) over trastuzumab emtansine but data regarding intracranial activity is limited. In the primary outcome analysis of TUXEDO-1, a high intracranial response rate (RR) was reported with T-DXd. Here, we report the final PFS and OS results. PATIENTS AND
methodsTUXEDO-1 accrued adult patients with HER2-positive BC and active BM (newly diagnosed or progressing) without indication for immediate local therapy. The primary endpoint was intracranial RR; secondary endpoints included PFS, OS, safety, quality-of-life (QoL), and neurocognitive function. PFS and OS were estimated with the Kaplan-Meier method and analyzed in the per-protocol population.
resultsAt 26.5 months median follow-up, median PFS was 21 months (95% CI: 13.3-n.r.) and median OS was not reached (95% CI: 22.2-n.r.). With longer follow-ups, no new safety signals were observed. The most common grade 3 adverse event was fatigue (20%). Grade 2 interstitial lung disease and a grade 3 symptomatic drop of left-ventricular ejection fraction were observed in one patient each. QoL was maintained over the treatment period.
conclusionsT-DXd yielded prolonged intra- and extracranial disease control in patients with active HER2-positive BC BM in line with results from the pivotal trials. These results support the concept of antibody-drug-conjugates as systemic therapy for active BM.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.