Trial reportESMO open2026
TRADE: tolerability of adjuvant abemaciclib at 6 months after initial dose escalation in patients with early-stage HR-positive/HER2-negative breast cancer.
Trial report in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdjuvant abemaciclib decreases recurrence rates and improves overall survival for patients with high-risk early-stage hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer. However, toxicity, particularly diarrhea, may lead to dose reductions and early discontinuation. Primary results of the TRADE trial demonstrated that early dose escalation of abemaciclib can help patients reach and maintain the target dose of 150 mg twice daily (b.i.d.) by 12 weeks on therapy. In this article, we report a preplanned analysis of clinical outcomes at 24 weeks of the study. PATIENTS AND
methodsTRADE is a prospective, investigator-initiated, single-arm, phase II trial that enrolled patients with early-stage node-positive HR-positive/HER2-negative breast cancer who were candidates for adjuvant abemaciclib. Patients initiated abemaciclib at 50 mg b.i.d. for 2 weeks, then 100 mg b.i.d. for 2 weeks, before escalating to 150 mg b.i.d. for the planned 2-year duration of therapy. We report key endpoints at 24 weeks.
resultsAmong 89 evaluable patients, 16 (18.0%) had discontinued abemaciclib by 24 weeks on therapy, including 7 (7.9%) who discontinued for adverse events. Among the 73 participants (82.0%) who were still receiving abemaciclib at 24 weeks, 47 (64.4%) were receiving 150 mg b.i.d., 18 (24.7%) were receiving 100 mg b.i.d., and 8 (11.0%) were receiving 50 mg b.i.d. Among all 89 assessable participants, 29 (32.6%) required at least one abemaciclib dose reduction, including 22 participants (24.7%) who had initially reached the 150 mg b.i.d. dose and then reduced. Patient-reported outcomes indicated no clinically meaningful change in quality of life from baseline through month 5 on therapy.
conclusionsFindings from the adjuvant TRADE study at 24 weeks of follow-up continue to demonstrate the utility of an early dose-escalation strategy during the initiation of adjuvant abemaciclib in optimizing patient persistence with and tolerability of therapy. Longer-term follow-up will continue to evaluate treatment outcomes over the planned 2 years of therapy.
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