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Protocol No. UW17010

Principal Investigator Barroilhet, Lisa

Phase II Pilot (Cancer Prevention)

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title Pilot Study of Daily Exemestane in Women with Complex Atypical Hyperplasia of the Endometrium / Endometrial Intraepithelial Neoplasia or Grade 1 Endometrial Cancer

Objective The purpose of this study is to gain additional information about the effect of the study drug, exemestane on cancerous and pre-cancerous cells of the uterine lining (endometrium). If exemestane decreases the growth of the uterine lining, it may be used in the future instead of a hysterectomy to prevent of treat uterine cancer.

Treatment Exemestane, an aromatase inhibitor (AI), is used for the primary chemoprevention of breast cancer in high-risk populations, as well as in the upfront and adjuvant treatment of women with advanced and local disease, respectively. Given its anti-estrogen effects, it holds promise as a potential therapeutic or chemopreventive intervention for women with (or at high-risk of developing) endometrial cancer.

Description Everyone enrolled in this study will receive exemestane (one 25 mg tablet) once a day for at least 3 weeks, but not longer than 6 weeks, ending on the day before surgery. The length an individual receives exemestane depends on the time between entering the study and the scheduled day of surgery.

Key Eligibility
  • Females with a histologically proven complex atypical hyperplasia (CAH)/endometrial intraepithelial neoplasia (EIN) or grade I endometrial carcinoma (EC) for which surgery is planned
  • No prior treatment for CAH/EIN/EC
  • Age ≥50 years
  • BMI > 20
  • If patient is not a surgical candidate or surgery is not scheduled within 43 days from starting the study drug they are ineligible
  • If patient has any gastrointestinal condition causing malabsorption or obstruction they are ineligible
  • If patient has been on any hormonal treatment (including progestin-containing IUD) for CAH/EIN or grade 1 endometrial carcinoma in last 3 months they are ineligible
  • If patient has concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s wort they are ineligible as these may significantly reduce the availability of exemestane
  • If patient has evidence or high suspicion of metastatic disease at enrollment they are ineligible
  • Women with severe bone density issues/osteoporosis (defined as any medical treatment for osteoporosis, and/or a T-score of -2.5 or lower, and/or history of fracture of the hip or spine) are ineligible
  • Patients who are unwilling or unable to undergo research biopsy during the baseline (pre-surgical) clinic visit, or inadequate research biopsy obtained during the baseline (pre-surgical) clinic visit (determined by the gynecologic oncologist at the time of the subject’s pelvic exam) are ineligible

Applicable Disease Sites Ovary

Therapies Involved Prevention

Drugs Involved aromasin (exemestane); exemestane

Status Open

Participating Institutions UW Hospital and Clinics; University of Minnesota, Masonic Cancer Center