Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a Phase 1b/2, open-label, parallel-arms pilot study in men and post-menopausal women with hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an alteration in the PI3K pathway, including a mutation of the PIK3CA gene, PTEN loss, or AKT1 mutation, designed to determine the safety of evexomostat (SDX-7320) plus standard of care treatment alpelisib (BYL-719) or capivasertib and fulvestrant (each combined, the 'triplet therapy'), to measure the severity and number of hyperglycemic events, and to assess clinical, anti-tumor benefit of the triplet therapy. The purpose of this study is: * to characterize the safety of the triplet drug combination consisting of either alpelisib or capivasertib (per the treating oncologist's choice) and fulvestrant plus evexomostat, * to test whether evexomostat, when given in combination with either alpelisib or capivasertib and fulvestrant will reduce the number and severity of hyperglycemic events and/or reduce the number or dose of anti-diabetic medications needed to control the hyperglycemia for metabolically normal patients and those deemed at risk for capivasertib and alpelisib-induced hyperglycemia (insulin resistance, as measured by HOMA-IR, baseline elevated HbA1c or well-controlled type 2 diabetes), and * to assess preliminary anti-tumor efficacy for each combination and changes in key biomarkers and quality of life in this patient population.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dorosły mężczyzna lub kobieta po menopauzie, lat 18 lub więcej, który podpisał zgodę na udział w badaniu.
- •Potwierdzona diagnoza raka piersi bez receptorów HER2, z receptorami hormonalnymi pozytywnym (HR+).
- •Mutacja genu PIK3CA lub utrata białka PTEN lub mutacja genu AKT1, potwierdzona zatwierdzoną metodą.
- •Zaawansowany lub przerzutowy rak piersi, który nie poddaje się wyleczeniu - wcześniej leczony lekami na bazie endokrynologii i inhibitorem CDK 4/6, lub nowo rozpoznany zaawansowany rak z pojawiającym się pogorszeniem podczas takiego leczenia.
- •Mierzalne zmiany nowotworu widoczne w badaniach obrazowych (tomografia lub rezonans).
- •Ogólny stan zdrowia pozwalający na aktywność - ocena ECOG ≤1.
- •Stężenie cukru na czczo ≤140 mg/dL oraz kontrolowany poziom HbA1c (zależy od przyjmowanego leku).
- •Wskaźnik masy ciała ≥20 kg/m².
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- April 22, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (10)
Loma Linda University Cancer Center
Loma Linda, United States
Hoag Memorial Hospital Presbyterian
Newport, United States
SHARP Healthcare
San Diego, United States
Miami Cancer Institute at Baptist Health
Miami, United States
Hope and Healing Cancer Services
Hinsdale, United States
Trinity Health
Ypsilanti, United States
Cleveland Clinic
Cleveland, United States
Penn State Milton S Hershey Medical Center
Hershey, United States
Vanderbilt University Medical Center
Nashville, United States
Doctors Hospital of Laredo
Laredo, United States
Trial contact
David Browning
James M Shanahan
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.