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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 Low Grade 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