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Avutometinib, Abemaciclib, and Fulvestrant in Patients with HR+/HER2- Metastatic Breast Cancer Previously Treated with CDK4/6 Inhibitor: A Single-Arm Phase I Trial

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To assess the safety and efficacy of avutometinib combined with abemaciclib and fulvestrant in patients with HR+/HER2- metastatic breast cancer after CDK4/6 inhibitor treatment.
16 patients treated with specified doses of abemaciclib, avutometinib, and fulvestrant.
Primary endpoint was maximum tolerated dose; secondary endpoints included safety and response rates.
Treatment administered for three weeks on, followed by one week off.
Maximum tolerated dose identified as abemaciclib 100 mg BID, avutometinib 3.2 mg BIW, fulvestrant 500 mg IM q28d.
Overall response rate was 13% with a 24-week clinical benefit rate of 40%.
Median progression-free survival was 3.6 months (95% CI: 2.1-not reached).

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Single-arm phase I trial evaluates efficacy of dual inhibitor therapy in HR+/HER2- breast cancer, suggesting promising results.

Waks et al. (2026) studied this question.

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