Study on Alpelisib and Fulvestrant for Treating Endometrial Cancer

Inclusion Criteria

• Have advanced endometrial cancer that cannot be cured with surgery or radiation.
• Cancer must be confirmed by a biopsy and show specific characteristics, including a PIK3CA mutation and positive estrogen receptor status.
• Have at least one tumor that can be measured by scans or exams.
• Previous chemotherapy or hormone therapy is allowed, but not previous treatment with fulvestrant.
• Must be able to swallow pills.
• Be in good overall health with a performance status of 0 to 2.
• Have controlled blood sugar levels.
• Have adequate organ function based on specific blood tests.
• Be at least 18 years old.
• Women of childbearing potential must have a negative pregnancy test and use effective contraception during and after the study.

Exclusion Criteria

• Have previously received fulvestrant or similar drugs targeting PIK3CA, PI3K, mTOR, or AKT.
• Have certain types of endometrial cancer, such as clear cell or serous types.
• Have allergies to alpelisib or fulvestrant.
• Have had major surgery recently and not fully recovered.
• Have uncontrolled diabetes or certain other medical conditions.
• Have a history of jaw bone problems.
• Have another active cancer or a history of other cancers within the past five years.
• Have active infections or certain viral infections like HIV or hepatitis.
• Have serious pre-existing medical conditions that could interfere with the study.
• Have a history of heart disease or certain heart conditions.
• Are pregnant or breastfeeding.
• Have untreated brain metastases.
• Have gastrointestinal issues that affect drug absorption.
• Plan to receive live vaccines during the study.
• Have active bleeding disorders.
• Are participating in another clinical trial or have recently participated in one.
• Cannot understand or comply with study requirements.