Exemestane for Endometrial Cancer

No longer recruiting at 4 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Hormone therapy, CYP3A4 inducers

Disqualifiers: Recent malignancies, Malabsorption, Hormone use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of exemestane, a medication, in treating women with certain early forms of endometrial cancer or pre-cancerous conditions. The researchers aim to determine if exemestane can inhibit tumor cell growth by blocking specific enzymes necessary for their development. Post-menopausal women planning surgery for low-grade endometrial cancer or complex atypical hyperplasia (a pre-cancerous condition) might be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as hormone replacement therapy and strong CYP3A4 inducers like rifampicin and St. John's wort, at least 3 months before starting. If you're on any of these, you may need to stop them to participate.

Is there any evidence suggesting that exemestane is likely to be safe for humans?

Research has shown that exemestane has promising safety results for treating certain types of endometrial cancer. In one study, exemestane was used in women with endometrial intraepithelial neoplasia (EIN) and low-grade endometrial cancer. The study found that exemestane helped stop cancer cells from growing, suggesting it could be an effective treatment for these conditions.

Exemestane is also approved for treating breast cancer, providing additional information about its safety. When used for breast cancer, patients have generally tolerated it well, with manageable side effects. This offers some reassurance about its use for other types of cancer.

While more safety data is being collected specifically for endometrial cancer, current evidence indicates that exemestane is generally well-tolerated. Participants should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Exemestane is unique because it targets endometrial cancer by reducing estrogen production, which fuels the growth of many cancer cells. Unlike the standard treatments for endometrial cancer, such as surgery, radiation, or chemotherapy, exemestane is an oral medication that specifically inhibits the aromatase enzyme, effectively lowering estrogen levels in the body. Researchers are excited about exemestane because it offers a potentially less invasive treatment option and might be effective for patients who aren't candidates for surgery or who have limited responses to other therapies.

What evidence suggests that exemestane might be an effective treatment for endometrial cancer?

Research has shown that exemestane yields promising results in treating certain types of endometrial cancer. In earlier studies, exemestane stopped the growth of abnormal cells in conditions like endometrial intraepithelial neoplasia (EIN) and low-grade endometrial cancer. Some patients with estrogen-responsive tumors experienced halted tumor growth, with a few achieving partial or complete improvements. This trial will evaluate exemestane's effectiveness for patients with specific endometrial conditions by blocking enzymes necessary for tumor growth. However, further research is needed to fully understand its efficacy. ^{1 2 4 6 7}

Who Is on the Research Team?

Britt K Erickson

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your white blood cell count is at least 3000 per microliter.

Your hemoglobin level is at least 9 grams per deciliter.

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

Exclusion Criteria

I had cancer treated with the intent to cure, and all treatments ended less than a year ago, except for skin cancer.

I am not scheduled for surgery within 43 days of starting the study drug.

You have a medical, psychiatric, or social condition that may make it difficult for you to follow the study requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive exemestane orally once daily over 21-42 days

3-6 weeks

Daily oral administration

Surgery

Participants undergo standard of care surgery between days 22-43

1 day

1 visit (in-person)

Follow-up

Participants with unresolved adverse events on day of surgery are followed up periodically

Up to 7 months

What Are the Treatments Tested in This Trial?

Interventions

• Exemestane

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (exemestane) Experimental Treatment 4 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.

Exemestane is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in United States as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in Canada as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in Japan as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Exemestane effectively suppresses aromatase and plasma estrogen levels in postmenopausal women with recurrent breast cancer, showing significant efficacy even in patients who have failed other treatments like tamoxifen and other aromatase inhibitors.

The drug has a favorable safety profile with mild toxicity primarily consisting of menopausal symptoms, and it has demonstrated an early survival advantage over megestrol acetate in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exemestane: a novel aromatase inactivator for breast cancer. Jones, SA., Jones, SE.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3924910/

Examestane in advanced or recurrent endometrial carcinoma In the ER positive patients the median overall survival (OS) time was 13.3 months (95% CI: 7.7-18.9), in the ER negative patients the corresponding numbers were ...

2. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-25-1878/766825/Pilot-Study-of-Daily-Exemestane-in-Women-with

Pilot Study of Daily Exemestane in Women with Endometrial ... In this pilot study, exemestane demonstrated antiproliferative effects in EIN and low-grade endometrial cancer. This agent warrants further ...

3. ascopubs.org ascopubs.org/doi/10.1200/jco.2006.24.18_suppl.5042

Exemestane in advanced and recurrent endometrial ... In 17 patients with ER positive tumors, 1 showed a complete response, 1 partial response and 6 have had stable disease for 3+ months (3 patients), 6+ months (2) ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa040331

A Randomized Trial of Exemestane after Two to Three ... Exemestane therapy after two to three years of tamoxifen therapy significantly improved disease-free survival as compared with the standard five years of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01965080?term=AREA%5BConditionSearch%5D(%22Endometrial%20Cancer%22)%20AND%20AREA%5BInterventionSearch%5D(%22Exemestane%22)&rank=1

Exemestane in Advanced and Recurrent Endometrial ... Study Overview​​ Patients With Advanced or recurrent endometrial cancer of endometrioid type were treated With Exemestane tablets 25 mg daily. Patients were ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305737209001923

Adjuvant aromatase inhibitor therapy: Outcomes and safety The Breast International Group (BIG) 1-98 trial, comparing the AI letrozole (LET) with TAM, has demonstrated the safety of initial adjuvant LET over 60.5 months ...

7. cancer.org cancer.org/cancer/types/endometrial-cancer/treating/hormone-therapy.html

Hormone Therapy for Endometrial Cancer Blocking these proteins in hormone receptor-positive uterine cancer cells helps stop the cells from dividing. This can slow cancer growth.