Trial · NCT03300557

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

NCT03300557, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2025-06-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer. Trials, record NCT03300557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03300557

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer
NCT number: NCT03300557
Status: Completed
Phases: Phase 2
Enrollment: 40 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Atypical Hyperplasia, Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia, Endometrial Carcinoma, FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
Interventions: Exemestane, Laboratory Biomarker Analysis, Pharmacokinetic Study, Questionnaire Administration
First posted: 2017-10-03
Last updated: 2025-08-29
Results first posted: 2025-06-03

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Tumor Proliferation	Baseline up to 2 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.
Secondary	Changes in Circulating Serum Estradiol	Baseline up to 2 months	Circulating serum estradiol pre and post treatment to determine the effect of daily dose of 25mg of exemestane for 21-42 days.
Secondary	Changes in Circulating Serum Progesterone	Baseline up to 2 months	Circulating serum progesterone pre and post treatment to determine the effect of daily dose of 25mg of exemestane for 21-42 days.
Secondary	Percent of Participants by Pathological Response Class at 2 Months	Up to 2 months	This measure assesses change in categories in pathological response. As pathological response is an ordered categorical variable with classes of No visible lesion, CAH/EIN, Grade I, Grade II, and Grade III in this study, a change in class from baseline to time of surgery represents a decrease or increase in disease severity.
Secondary	Change From Baseline in Percent of Cells Positive for Tissue Markers	Up to 2 months	Assessment of change from baseline for apoptosis (cleaved caspase 3), proliferation (cyclin D1), insulin pathway (pAKT, IGF-1R), and endocrine regulation (estrogen receptor/progesterone receptor/androgen receptor). The units for absolute change in is % Positive.
Secondary	Deoxyribonucleic Acid (DNA) Mutational Analysis	Up to 2 months	Will be analyzed by next generation sequencing.
Secondary	Protein Markers	Up to 2 months	Perform pre- and post-treatment proteomic analysis of vaginal proteins from tampon recovery to identify biomarkers that may predict response to exemestane treatment.
Secondary	Ki-67 Expression With Historic Controls	Up to 2 months	Will compare Ki-67 expression between participants samples and historically matched samples.
Secondary	Plasma Levels of Exemestane	Up to 2 months	Will evaluate plasma levels of exemestane pre and post treatment.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Tumor Proliferation	Baseline up to 2 months	There was not enough tissue to analyze from the other two participants	percent (represented by mean) of cells	MEAN
SECONDARY	Changes in Circulating Serum Estradiol	Baseline up to 2 months	Site did not collect data on the 3 participants omitted from the count	pg/mL	MEAN
SECONDARY	Changes in Circulating Serum Progesterone	Baseline up to 2 months	Site did not collect the relevant information for the omitted 3 participants	ng/mL	MEAN
SECONDARY	Percent of Participants by Pathological Response Class at 2 Months	Up to 2 months		Percent of participants	NUMBER
SECONDARY	Change From Baseline in Percent of Cells Positive for Tissue Markers	Up to 2 months	N=37 for caspase because there was not enough tissue on slide for 2 and 1 block was not sent. N=36 for cyclin D1 because 3 were missing data and 1 block was not sent. N=35 for pAKT because 3 were missing data, 1 did not have enough tissue, and 1 block was not sent. N=22 for IGF-1R because 1 black was not sent, 5 did not have enough tissue, and the rest are missing data.	% positive	MEAN
SECONDARY	Deoxyribonucleic Acid (DNA) Mutational Analysis	Up to 2 months	Samples were collected from participants. After enrollment was completed, the intended laboratory was no longer available to process the samples. There are no data to report and there is no intent to analyze these samples in the future.	percentage of cells	NUMBER
SECONDARY	Protein Markers	Up to 2 months	Tampon submission was optional and not all participants submitted tampon samples.	number of proteins	NUMBER
SECONDARY	Ki-67 Expression With Historic Controls	Up to 2 months		percentage of cells	MEAN
SECONDARY	Plasma Levels of Exemestane	Up to 2 months	40th specimen was not collected by the site.	ng/mL	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Tumor Proliferation	Treatment (Exemestane)		-0.17	Standard Deviation 0.22	percent (represented by mean) of cells
Changes in Circulating Serum Estradiol	Treatment (Exemestane)		4.08	Standard Deviation 13.81	pg/mL
Changes in Circulating Serum Progesterone	Treatment (Exemestane)		0.22	Standard Deviation 0.27	ng/mL
Percent of Participants by Pathological Response Class at 2 Months	Treatment (Exemestane)	No visible lesion	2.5		Percent of participants
Percent of Participants by Pathological Response Class at 2 Months	Treatment (Exemestane)	CAH/EIN	20		Percent of participants
Percent of Participants by Pathological Response Class at 2 Months	Treatment (Exemestane)	Grade I (Low) EC	57.5		Percent of participants
Percent of Participants by Pathological Response Class at 2 Months	Treatment (Exemestane)	Grade II (Low) EC	10		Percent of participants
Percent of Participants by Pathological Response Class at 2 Months	Treatment (Exemestane)	Grade III (High) EC	10		Percent of participants
Change From Baseline in Percent of Cells Positive for Tissue Markers	Treatment (Exemestane)	Cleaved capsase	-0.17	Standard Deviation 0.18	% positive
Change From Baseline in Percent of Cells Positive for Tissue Markers	Treatment (Exemestane)	Cyclin D1	-0.07	Standard Deviation 0.22	% positive

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (Exemestane)	40
Overall Study	COMPLETED	Treatment (Exemestane)	40
Overall Study	NOT COMPLETED	Treatment (Exemestane)	0

Source ClinicalTrials.gov

Adverse events45

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hot flashes	Vascular disorders	Treatment (Exemestane)	21	40
other	Hypertension	Vascular disorders	Treatment (Exemestane)	17	40
other	Flushing	Vascular disorders	Treatment (Exemestane)	1	40
other	Diarrhea	Gastrointestinal disorders	Treatment (Exemestane)	10	40
other	Abdominal pain	Gastrointestinal disorders	Treatment (Exemestane)	8	40
other	Constipation	Gastrointestinal disorders	Treatment (Exemestane)	5	40
other	Nausea	Gastrointestinal disorders	Treatment (Exemestane)	4	40
other	Vomiting	Gastrointestinal disorders	Treatment (Exemestane)	4	40
other	Bloating	Gastrointestinal disorders	Treatment (Exemestane)	2	40
other	Dyspepsia	Gastrointestinal disorders	Treatment (Exemestane)	1	40

1 to 10 of 45Source ClinicalTrials.gov

See all 45 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Exemestane)	0	40
Total, other adverse events	Treatment (Exemestane)	38	40
Total, serious adverse events	Treatment (Exemestane)	0	40

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA014520	UW Comprehensive Cancer Center Support	CAPITINI, CHRISTIAN	UNIVERSITY OF WISCONSIN-MADISON	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03300557

GET https://conductscience.org/api/trials/v1/NCT03300557/events?page=2

API reference For AI assistants