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Aromatase Inhibitor

Exemestane for Endometrial Cancer

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

Must not have

Participants who had curatively treated invasive malignancies for which all treatments ended within 1 year prior to the study (with the exception of basal cell or squamous cell carcinoma of the skin)

Any gastrointestinal condition causing malabsorption or obstruction (e.g. celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

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

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

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

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I can and will take pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have any stomach or intestine conditions that affect food absorption or cause blockages.

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I am not willing or able to have a biopsy before surgery.

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My cancer is suspected to have spread to other parts of my body.

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I have been on hormonal treatment for CAH/EIN or low-grade endometrial cancer in the last 3 months.

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I am not taking medications like rifampicin or St. John's wort.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in tumor proliferation

Secondary study objectives

Deoxyribonucleic acid (DNA) mutational analysis

Ki-67 expression

Pathological response to exemestane

+3 more

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507

63%

Neutrophil count decreased

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Diarrhea

17%

Headache

17%

Mucositis

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Flu like symptoms

10%

Obesity

Pain in extremity

Constipation

Fever

Pruritus

Bone pain

Dizziness

Dyspepsia

Hot flashes

Dysgeusia

Pain

Nail disorder

Respiratory infection

Abdominal pain

Osteonecrosis of jaw

Spinal cord compression

Heart failure

Bronchial infection

Pleural effusion

Ascites

Urinary tract infection

Breast infection

Dyspnea

Gallbladder infection

Renal failure

Dislocation of hip

Palmar-plantar erythrodysesthesia syndrome

Thromboembolic event

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Palbociclib Plus Fulvestrant

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~7510

0 / 11Eligibility criteria met