Chapters Transcript Video TRADE Study Presented by Erica Mayer, MD. Dr. Erica Mayer shares results from the TRADE study showing a successful abemaciclib dose escalation strategy in patients with HR+ breast cancer. I'm really excited to present the phase two trade study at ESCO 2025 this year. Just as some background, uh, Abemacycllib is an oral CDK46 inhibitor, and this drug has a very important role in the management of high risk node positive, hormone receptor positive, HER2 negative early breast cancer, because it can reduce the risk of breast cancer recurrence. However, therapy with Abema can be complicated by toxicity. And this can reduce a patient's ability to receive maximum benefit from the medicine. There are some experiences with other novel therapies that use an initial dose escalation strategy to try to help reduce toxicity and prevent drug discontinuation. So this is why we designed trade, which is again a prospective investigator initiated phase 2 study to see if using this dose escalation with a BEA could help improve drug tolerability and reduce discontinuation. Eligible patients for the trade study were patients who were already candidates to receive adjuvanibamacyclin. These patients started at a low dose of 50 mg twice a day for two weeks, and then if they were doing OK without significant ongoing toxicity, escalated to a dose, 100 mg twice a day for 2 weeks, and then escalated to the target dose 150 mg twice a day moving forward. The primary end point of the study was a composite adverse event rate that we measured at 12 weeks. This included discontinuation of Abemacycllib, inability to reach the target dose, or inability to maintain the target dose. And the study was designed to demonstrate a significant improvement in this adverse event rate compared to what was seen in the registration monarchy study. So we enrolled 90 patients at Dana-Farber, and of these patients, 70% were able to reach the target dose using the dose escalation strategy. 26 of the patients, or 29%, did meet the primary endpoint, but this was a significantly lower number than was seen in Monarchy. So this suggests that the dose escalation strategy improved outcomes. We also noted in our data that for patients who are unable to reach target dose, that most of them were able to continue at one of the lower doses, and only a very small percentage had to stop early. So in summary, our study, trade study suggested that using the initial Abemacyclli dose escalation strategy allowed the majority of patients to reach and maintain target dosing by 12 weeks, and only very few patients had to discontinue therapy. Published June 11, 2025 Created by Related Presenters Erica Mayer, MD, MPH Institute PhysicianAssistant Professor of Medicine, Harvard Medical School Dr. Mayer is a medical oncologist and clinical investigator in the Breast Oncology Center. View full profile
