Study on Giredestrant for Patients with Grade 1 Endometrial Cancer

Inclusion Criteria

• Have a confirmed diagnosis of Grade 1 endometrial cancer and be willing to receive six cycles of the study treatment.
• Provide a recent endometrial biopsy or sample for confirmation.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• MRI confirmation that the tumor is not deeply invasive and no spread outside the uterus.
• Willing to undergo at least six cycles of therapy before deciding on surgery.
• No previous treatment for endometrial cancer.
• Able to take oral medications.
• Willing to follow the study schedule, including visits and tests.
• Have adequate blood and organ function.
• Negative HIV test, unless stable on treatment with a controlled viral load.
• Women of childbearing potential must agree to use contraception or remain abstinent during treatment and for 30 days after the last dose.

Exclusion Criteria

• Pregnant or breastfeeding, or planning to become pregnant during the study or shortly after.
• Have a type of endometrial cancer other than Grade 1, such as serous or clear cell.
• Have received any investigational therapy or cancer treatment within 28 days before starting the study.
• Have digestive issues that affect absorption, like celiac disease or past gastric surgery.
• Allergic to giredestrant or its ingredients.
• Have other illnesses or psychiatric conditions that could interfere with the study.
• Evidence of cancer spread outside the uterus.
• Unable to comply with study procedures, including biopsies.
• Planned surgery during the study period.
• Recent serious infections or active infections that could affect safety.
• Significant liver disease or active hepatitis.
• Taking certain medications that affect drug processing in the body.
• Any serious medical condition that could make participation unsafe.
• History of other cancers within the last five years, except for certain low-risk cancers.
• Active tuberculosis or severe infections.
• Significant heart disease or recent heart events.
• Major surgery within 28 days before starting the study.
• Previous bone marrow or organ transplant.
• Any condition that could interfere with understanding or following the study.