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Study to Assess the Safety and Efficacy of Evexomostat (SDX-7320) in Combination With A PI3K or Akt Inhibitor Plus Fulvestrant in Patients With HR+, HER2-, Metastatic Breast Cancer With PI3K Pathway Alteration(s)

What is this study?

This study is testing a new drug combination for people with a specific type of advanced breast cancer that has spread to other parts of the body. The goal is to see if adding a new medicine called 'evexomostat' to standard treatments can fight the cancer more effectively while also reducing common side effects like high blood sugar.

Who can participate?

This trial is for men and post-menopausal women with HR+, HER2- breast cancer that has specific genetic changes in the PI3K pathway. You must have advanced or metastatic cancer, and your doctor will check if your specific tumor profile matches what this study is looking for.

What will happen?

Participants will receive a 'triplet therapy,' which means taking a combination of three different drugs to treat the cancer. During the study, your medical team will closely monitor your blood sugar levels, tumor response, and overall quality of life to ensure the treatment is safe and effective for you.

Where and when?

The study is currently recruiting patients at locations in Loma Linda, Newport, and San Diego, California. You should talk to your oncology team to see if one of these centers is a good fit for your care.

Key Points
  • 1Researchers are testing if adding evexomostat can help manage blood sugar levels caused by standard cancer medications.
  • 2This is a Phase 1/2 study, which is an important step in learning how well this new drug combination works.
  • 3The study focuses on patients whose cancer has specific genetic markers known as PI3K pathway alterations.

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Conditions Studied
This study is investigating treatments for the following conditions
HR+/HER2-negative Breast CancerMetastatic Breast Cancer

This summary was generated using AI and may not capture all details. Always consult with a healthcare professional for medical advice.