Your session is about to expire
← Back to Search
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had cancer treated with the intent to cure, and all treatments ended less than a year ago, except for skin cancer.
Select...
I do not have any stomach or intestine conditions that affect food absorption or cause blockages.
Select...
I am not willing or able to have a biopsy before surgery.
Select...
My cancer is suspected to have spread to other parts of my body.
Select...
I have been on hormonal treatment for CAH/EIN or low-grade endometrial cancer in the last 3 months.
Select...
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
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 moreSide effects data
From 2021 Phase 3 trial • 693 Patients • NCT0202850763%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Headache
17%
Mucositis
17%
Diarrhea
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Cough
11%
Upper respiratory infection
10%
Obesity
10%
Flu like symptoms
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Dizziness
7%
Dyspepsia
7%
Hot flashes
7%
Bone pain
7%
Pruritus
5%
Pain
5%
Dysgeusia
3%
Abdominal pain
3%
Respiratory infection
3%
Nail disorder
1%
Spinal cord compression
1%
Heart failure
1%
Pleural effusion
1%
Ascites
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Dislocation of hip
1%
Renal failure
1%
Bronchial infection
1%
Urinary tract infection
1%
Thromboembolic event
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Osteonecrosis of jaw
1%
Cholecystitis acute
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,142 Total Patients Enrolled
Britt K EricksonPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
525 Total Patients Enrolled