Evexomostat with PI3K/AKT Inhibitor and Fulvestrant for HR+/HER2- Breast Cancer
This study is for adult men and postmenopausal women with hormone receptor-positive (HR+), HER2-negative metastatic breast cancer. You may be eligible if your cancer has a change in the PI3K pathway, such as a PIK3CA mutation, PTEN loss, or AKT1 mutation. The study is testing the safety and effectiveness of a combination of three drugs: evexomostat, plus either alpelisib or capivasertib, and fulvestrant. Researchers want to see how well this "triplet therapy" works to shrink tumors and how many patients experience high blood sugar (hyperglycemia), which can be a side effect of some of these drugs. The study aims to understand the side effects and benefits of this new combination.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 52 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for side effects for up to 48 months, and for high blood sugar events for up to 42 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer
At a glance
Conditions
Where it's being run
10 sites across 8 statesStudy leadership
- Medical Team · STUDY_DIRECTOR · SynDevRx, Inc.
Who to contact
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What this trial measures
- Incidence of Adverse EventsUp to 48 months
Safety and tolerability profile will be assessed by Common Terminology Criteria for Adverse Events v5.0 and summarized by type, frequency, and severity of adverse events of evexomostat dosed in combination with alpelisib plus fulvestrant
- Hyperglycemic EventsUp to 42 months
Severity, number, and proportion of patients with hyperglycemic events