Trials / Completed
CompletedNCT03300557
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- Female
- Age
- 45 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
PRIMARY OBJECTIVE: I. To determine if there is a decrease in proliferation index, measured by Ki-67 expression, in complex atypical hyperplasia (CAH)/endometrial intraepithelial neoplasia (EIN) or low grade (grade 1 and grade 2) endometrial cancer cells from baseline to post-exemestane treatment. SECONDARY OBJECTIVES: I. Circulating serum estradiol and progesterone. II. Pathological response (regression of CAH/EIN or low grade \[grade 1 and grade 2\] endometrial carcinoma). III. Tissue biomarkers. IV. Deoxyribonucleic acid (DNA) mutational analysis through next generation sequencing and methylation status of endometrial tumor. V. Protein markers via tampon recovery before and after treatment. VI. DNA markers via tampon recovery. VII. Safety and adverse effects of treatment. VIII. Comparison of Ki-67 expression changes between study subjects and a historical cohort. IX. Evaluation of the levels of exemestane in the plasma samples pre and post treatment. OUTLINE: Patients receive exemestane orally (PO) once daily (QD) over 21-42 days in the absence of disease progression or unaccepted toxicity. Patients undergo standard of care surgery between days 22-43. After completion of study treatment, patients with unresolved adverse events on day of surgery are followed up periodically.
Conditions
- Atypical Hyperplasia
- Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia
- Endometrial Carcinoma
- FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
- FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Exemestane | Given PO |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| OTHER | Pharmacokinetic Study | Correlative studies |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2017-11-15
- Primary completion
- 2023-12-13
- Completion
- 2025-08-14
- First posted
- 2017-10-03
- Last updated
- 2025-08-29
- Results posted
- 2025-06-03
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03300557. Inclusion in this directory is not an endorsement.