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Phase 2 N=40 Prevention

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

Atypical Hyperplasia · Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia · Endometrial Carcinoma · FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma · FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Tumor Proliferation — -0.17 percent (represented by mean) of cells

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Exemestane (Drug); Laboratory Biomarker Analysis (Other); Pharmacokinetic Study (Other); Questionnaire Administration (Other)
Age
Adult, Older Adult · 45+ yrs
Sex
Female
Sponsor
National Cancer Institute (NCI)
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Tumor Proliferation
-0.17
SECONDARY
Changes in Circulating Serum Estradiol
4.08
SECONDARY
Changes in Circulating Serum Progesterone
0.22
SECONDARY
Percent of Participants by Pathological Response Class at 2 Months
2.5; 20; 57.5; 10; 10
SECONDARY
Change From Baseline in Percent of Cells Positive for Tissue Markers
-0.17; -0.07; -0.12; -2.50
SECONDARY
Deoxyribonucleic Acid (DNA) Mutational Analysis
NA
SECONDARY
Protein Markers
85
SECONDARY
Ki-67 Expression With Historic Controls
-0.07
SECONDARY
Plasma Levels of Exemestane
2.51

Summary

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

Inclusion Criteria

  • 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 = 9 g/dL
  • Serum creatinine = = 60 mL/min using Cockcroft-Gault equation for patients with creatinine levels > 1.5 x institutional upper limit of normal (ULN)
  • Total bilirubin = = 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

Exclusion Criteria

  • 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
  • Any gastrointestinal condition causing malabsorption or obstruction (e.g. celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
  • 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
  • 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
  • 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)
  • 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03300557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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