Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-31 @ 9:11 PM
Study NCT ID:
NCT03300557
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2017-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Pilot Study of Daily Exemestane in Women With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-01782 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| UW17010 | None | None | View | |
| N01-CN-2012-00033 | None | None | View | |
| 2016LS183 / UWI17010/UAB1788 | OTHER | University of Wisconsin Carbone Cancer Center - University Hospital | View | |
| UWI2016-08-01 | OTHER | DCP | View | |
| N01CN00033 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA014520 | NIH | None | https://reporter.nih.gov/quic… | View |