Exemestane for Endometrial Cancer

Palo Alto (17 mi)

Overseen byBritt K Erickson

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This pilot phase IIa trial studies how well exemestane works in treating patients with complex atypical hyperplasia of the endometrium/endometrial intraepithelial neoplasia or low grade endometrial cancer. Exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

This trial is for postmenopausal women with complex atypical hyperplasia or low grade endometrial cancer who haven't had prior treatments. Participants must have adequate organ function, no recent invasive malignancies except certain skin cancers, not be on hormone therapy or strong CYP3A4 inducers, and able to take oral medications.

Inclusion Criteria

I am fully active and can carry on all pre-disease activities without restriction.

I have not received treatment for CAH, EIN, or EC.

I am confirmed to be post-menopausal based on my age or hormone levels.

My kidney function, measured by creatinine levels, is within the normal range.

I can and will take pills.

Exclusion Criteria

I had cancer treated with the intent to cure, and all treatments ended less than a year ago, except for skin cancer.

I do not have any stomach or intestine conditions that affect food absorption or cause blockages.

I am not willing or able to have a biopsy before surgery.

My cancer is suspected to have spread to other parts of my body.

I have been on hormonal treatment for CAH/EIN or low-grade endometrial cancer in the last 3 months.

I am not taking medications like rifampicin or St. John's wort.

Treatment Details

The trial tests exemestane's effectiveness in treating specific endometrial conditions by blocking enzymes that promote cell growth. It includes a pharmacokinetic study to see how the body processes the drug, biomarker analysis, and questionnaires.

1Treatment groups

Experimental Treatment

Group I: Treatment (exemestane)Experimental Treatment4 Interventions

Patients receive exemestane PO QD over 21-42 days in the absence of disease progression or unaccepted toxicity. Patients undergo standard of care surgery between days 22-43.

Exemestane is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Aromasin for: