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Aromatase Inhibitor

Exemestane for Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia

Q: Is it possible to sign up for this clinical trial at this time?

Unfortunately, this study is not currently recruiting participants. The listing was first posted on November 15th, 2017 and the most recent edit occurred on September 23rd, 2022. However, there are 3619 other trials for patients with carcinoma endometrioid and 60 trials for Exemestane that are actively looking for candidates.

Q: Has Exemestane been sanctioned by the FDA?

Exemestane's safety is based on Phase 2 trial data, meaning that while there is some evidence to support its safety, none exists yet for its efficacy. Therefore, we have given it a score of 2.

Q: Are there similar treatments to Exemestane?

At present, 60 Exemestane clinical trials are underway. 23 of these active studies are classified as Phase 3. The largest concentration of research is based in Pisa, PI; however, 7740 total locations worldwide are conducting investigations into this treatment.

Q: How many people have been invited to participate in this clinical trial?

This particular trial is not presently looking for any more patients as it has already hit its recruitment limit. The clinical trial was initially posted on 11/15/2017 and was last updated on 9/23/2022. However, if you are searching for other studies, there are currently 3619 clinical trials actively looking for participants with carcinoma, endometrioid and 60 studies for Exemestane that are still recruiting.

Q: For what medical purpose is Exemestane most commonly employed?

Women in postmenopause, who have an advance directive in place and have taken tamoxifen for 2 to 3 years can be treated with Exemestane.

Phase 2

Waitlist Available

Led By Britt K Erickson

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 1

No prior treatment for CAH/EIN/EC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 months

Awards & highlights

Study Summary

This trial looks at how well exemestane works in treating patients with endometrial cancer or abnormal cell growth in the endometrium. Exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for postmenopausal women with complex atypical hyperplasia or low grade endometrial cancer who haven't had prior treatments. Participants must have adequate organ function, no recent invasive malignancies except certain skin cancers, not be on hormone therapy or strong CYP3A4 inducers, and able to take oral medications.Check my eligibility

What is being tested?

The trial tests exemestane's effectiveness in treating specific endometrial conditions by blocking enzymes that promote cell growth. It includes a pharmacokinetic study to see how the body processes the drug, biomarker analysis, and questionnaires.See study design

What are the potential side effects?

Exemestane may cause joint pain, hot flashes, fatigue, osteoporosis (bone thinning), mood swings and slight nausea. Since it lowers estrogen levels in the body which can affect bone density and cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active and can carry on all pre-disease activities without restriction.

Select...

I have not received treatment for CAH, EIN, or EC.

Select...

I am confirmed to be post-menopausal based on my age or hormone levels.

Select...

My kidney function, measured by creatinine levels, is within the normal range.

Select...

I can and will take pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in tumor proliferation

Secondary outcome measures

Changes in circulating serum estradiol

Changes in circulating serum progesterone

Deoxyribonucleic acid (DNA) mutational analysis

+6 more

Side effects data

From 2013 Phase 3 trial • 4740 Patients • NCT00038467

22%

Hot flushes NOS

18%

Arthralgia

16%

Fatigue

14%

Headache

13%

Insomnia

12%

Sweating increased

10%

Dizziness

10%

Hypertension NOS

Back pain

Nausea

Depression

Pain in limb

Osteoarthritis NOS

Weight increased

Osteoporosis NOS

Vaginal haemorrhage

Abdominal pain

Condition aggravated

100%

80%

60%

40%

20%

Study treatment Arm

Exemestane

Tamoxifen

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (exemestane)Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exemestane

2003

Completed Phase 4

~7880

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,325 Total Patients Enrolled

1 Trials studying Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia

50 Patients Enrolled for Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia

Britt K EricksonPrincipal InvestigatorUniversity of Wisconsin, Madison

1 Previous Clinical Trials

525 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to sign up for this clinical trial at this time?

"Unfortunately, this study is not currently recruiting participants. The listing was first posted on November 15th, 2017 and the most recent edit occurred on September 23rd, 2022. However, there are 3619 other trials for patients with carcinoma endometrioid and 60 trials for Exemestane that are actively looking for candidates."

Answered by AI

Has Exemestane been sanctioned by the FDA?

"Exemestane's safety is based on Phase 2 trial data, meaning that while there is some evidence to support its safety, none exists yet for its efficacy. Therefore, we have given it a score of 2."

Answered by AI

Are there similar treatments to Exemestane?

"At present, 60 Exemestane clinical trials are underway. 23 of these active studies are classified as Phase 3. The largest concentration of research is based in Pisa, PI; however, 7740 total locations worldwide are conducting investigations into this treatment."

Answered by AI

How many people have been invited to participate in this clinical trial?

"This particular trial is not presently looking for any more patients as it has already hit its recruitment limit. The clinical trial was initially posted on 11/15/2017 and was last updated on 9/23/2022. However, if you are searching for other studies, there are currently 3619 clinical trials actively looking for participants with carcinoma, endometrioid and 60 studies for Exemestane that are still recruiting."

Answered by AI