TRADE: tolerability of adjuvant abemaciclib at 6 months after initial dose escalation in patients with early-stage HR-positive/HER2-negative breast cancer.

Authors

I Schlam, D Trapani, S-E Kim, H Heiling, M Faggen, N Sinclair, P Sanz-Altamira, C Battelli, S Berwick, S Lo, J Acevedo, S Sinclair, A Malcolm, L Varella, S Sammons, S Schumer, P D Poorvu, E Wallace, E Pasternak, N Tayob, S M Tolaney, E L Mayer

Published in

ESMO open. Volume 11. Issue 7. Pages 108247. Jul 06, 2026. Epub Jul 06, 2026.

Abstract

Adjuvant 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.
TRADE 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.
Among 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.
Findings 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.

PMID:
42407196
Bibliographic data and abstract were imported from PubMed on 07 Jul 2026.

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