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NCT03300557CompletedPhase 2

Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer

Pilot Study of Daily Exemestane in Women With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer

Source: ClinicalTrials.gov · Last updated 29 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (actual)
First submitted
2 Oct 2017
Start date
15 Nov 2017
Primary completion date
13 Dec 2023
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT03300557

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 40
  • From 15 Nov 2017 to the primary completion date, 13 Dec 2023
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who had curatively treated invasive malignancies for which all treatments ended within 1 year prior to the study (with the exception of basal cell or squamous cell carcinoma of the skin)
  • Not a surgical candidate or surgery is not scheduled within 43 days from starting the study drug
  • Receiving any other investigational agents
  • Use hormone replacement therapy (including systemic or topical estrogen, progesterone, or testosterone based medication) or/and phytoestrogen supplements (i.e. black cohosh) or has been on progestin (including progestin containing IUD), tamoxifen or aromatase inhibitor within the prior 3 months
  • Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's wort as these may significantly reduce the availability of exemestane
  • 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)

Other illness

  • Any gastrointestinal condition causing malabsorption or obstruction (e.g. celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
  • Known hypersensitivity to exemestane or its excipients
  • Known intercurrent illness or psychiatric illness/social situations that will limit compliance with study requirements
  • Evidence or high suspicion of metastatic disease at enrollment
  • 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)

Other

  • Has been on any hormonal treatment (including progestin-containing intrauterine device \[IUD\]) for CAH/EIN or low grade (grade 1 or grade 2) endometrial carcinoma in last 3 months

Who the study is looking for

  • Females with a histologically proven CAH/ EIN or low grade (grade 1 or grade 2) endometrial carcinoma (EC) for which surgery is planned; the pathologic report from the referring facility will be used to determine pathologic eligibility; this report must be within 45 days of their baseline (pre-surgical) clinic visit
  • No prior treatment for CAH/EIN/EC
  • Post-menopausal confirmed with one the following criteria:
    • \>= 60 years of age
    • Age 56 to 59 years of age with \>= 2 years of amenorrhea
    • Age 56 to 59 years of age with \< 2 years of amenorrhea and follicle stimulating hormone (FSH) within institutional post-menopausal range.
    • Age 45 to 55 years of age with FSH within institutional post-menopausal range. The Ki-67 expression changes based on menopausal status and specifically varies based on what phase of the menstrual cycle the sample is collected. Therefore, in order to eliminate this source of variability, only postmenopausal women will be included in this trial. In addition, exemestane is currently approved for use in post-menopausal women only.
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
  • Hemoglobin \>= 9 g/dL
  • Serum creatinine =\< 1.5 x upper limit of normal or calculated creatinine clearance \>= 60 mL/min using Cockcroft-Gault equation for patients with creatinine levels \> 1.5 x institutional upper limit of normal (ULN)
  • Total bilirubin =\< 1.5 x ULN OR direct bilirubin =\< 1 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
  • White blood cell (WBC) \>= 3000/mcl
  • Platelets \>= 100,000/mcl
  • Able and willing to take oral medications
  • Ability to understand and the willingness to sign a written informed consent document
  • Body mass index (BMI) \> 20

Age in the registry: 45 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alabama at Birmingham Cancer Center
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center - University Hospital
Coordinator of this site? Confirm its status
MadisonUnited StatesUnknown status
University of Minnesota/Masonic Cancer Center
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.