Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT03300557|
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atypical Hyperplasia Endometrial Intraepithelial Neoplasia FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma||Drug: Exemestane Other: Laboratory Biomarker Analysis Other: Pharmacokinetic Study Other: Questionnaire Administration||Phase 2|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Daily Exemestane in Women With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer|
|Actual Study Start Date :||November 15, 2017|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Treatment (exemestane)
Patients receive exemestane PO QD over 21-42 days in the absence of disease progression or unaccepted toxicity. Patients undergo standard of care surgery between days 22-43.
Other: Laboratory Biomarker Analysis
Other: Pharmacokinetic Study
Other: Questionnaire Administration
- Change in tumor proliferation [ Time Frame: Baseline up to 7 months ]Will be measured by change in Ki-67 expression. Will evaluate the change from baseline to post-exposure in absolute change in percent Ki-67 using one-sample Student's t-test or Wilcoxon signed-rank test, as appropriate.
- Changes in circulating serum estradiol [ Time Frame: Baseline up to 7 months ]
- Changes in circulating serum progesterone [ Time Frame: Baseline up to 7 months ]
- Pathological response to exemestane [ Time Frame: Up to 7 months ]Will assess regression of complex atypical hyperplasia/endometrial intraepithelial neoplasia and low grade (grade 1 and grade 2) endometrial carcinoma.
- Tissue marker analysis [ Time Frame: Up to 7 months ]Will assess apoptosis (cleaved caspase 3), proliferation (cyclin D1), insulin pathway (pAKT, IGF-1R), and endocrine regulation (estrogen receptor/progesterone receptor/androgen receptor).
- Deoxyribonucleic acid (DNA) mutational analysis [ Time Frame: Up to 7 months ]Will be analyzed by next generation sequencing.
- Methylation status of endometrial tumor [ Time Frame: Up to 7 months ]
- Protein and DNA markers [ Time Frame: Up to 7 months ]Will be assessed via tampon recovery pre and post exemestane treatment.
- Ki-67 expression [ Time Frame: Up to 7 months ]Will compare Ki-67 expression between participants samples and historically matched samples.
- Plasma levels of exemestane [ Time Frame: Up to 7 months ]Will evaluate plasma levels of exemestane pre and post treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300557
|United States, Alabama|
|University of Alabama at Birmingham Cancer Center||Suspended|
|Birmingham, Alabama, United States, 35233|
|United States, Minnesota|
|University of Minnesota/Masonic Cancer Center||Suspended|
|Minneapolis, Minnesota, United States, 55455|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Howard H. Bailey 608-263-8624 firstname.lastname@example.org|
|Principal Investigator: Howard H. Bailey|
|Galliera Hospital||Not yet recruiting|
|Genoa, Italy, 16128|
|Contact: Andrea De Censi 39 010 5634501 email@example.com|
|Principal Investigator: Andrea De Censi|
|Principal Investigator:||Britt K Erickson||University of Wisconsin, Madison|